Association Between IVUS and OCT Parameters and Invasive Physiologic Indices

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03795714
• Collaborator: Samsung Medical Center (Other)
• Enrollment: 166
• Locations: 2
• Anticipated Duration (Months): 16.4
• Patients Per Site: 83
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

1. to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices.

2. to explores the association between intravascular imaging-derived plaque characteristics and invasive physiologic indices.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease	Diagnostic Test: IVUS or OCT and Invasive physiologic indices

Detailed Description

Given the inherent limitations of coronary angiography to depict the presence of functionally significant epicardial coronary stenosis and discrepancy between angiographic stenosis severity and the presence of myocardial ischemia, invasive physiologic indices such as fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard method to guide decision of revascularization.

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are an intracoronary imaging method able to provide information about lumen area, vessel area, plaque burden, and plaque characteristics that can be used for the guidance of revascularization procedure. Several previous studies explored the diagnostic performance of intravascular imaging-defined quantitative parameters to predict functional significance defined by FFR, however, quantitative parameter derived from intravascular imaging showed only moderate diagnostic accuracy and the optimal cut-off value of intravascular imaging-derived minimal lumen area (MLA) or minimal lumen diameter (MLD) were varied according to the patient population, interrogated vessels, and the location of target lesions, suggesting limited clinical relevance of judging functional significance of target stenosis using intravascular imaging alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various reasons and intravascular image-guided decision has been still used in substantial proportion of the patients.

Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does not require administration of hyperemic agents, therefore, possess more convenient in daily practice. Recent study with the largest sample size demonstrated identical diagnostic property and prognostic implication among iFR, RFR, and dPR. As those resting pressure-derived indices might have more generalizability for daily practice, it is expected to raise the adoption rate of physiologic interrogation. Therefore, understanding the association between all the available physiologic indices and intravascular imaging-derived quantitative and qualitative parameters might be important in clinical decision for patient who underwent invasive coronary angiography.

In this regard, the investigators sought to evaluate diagnostic accuracy and performance of intravascular imaging-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices and further explores the association between IVUS and OCT-derived plaque characteristics and invasive physiologic indices.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 166 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Intravascular Ultrasound and Optical Coherence Tomography-Defined Optimal Criteria and Plaque Characteristics for Defining the Functional Significance of Coronary Stenoses Using Resting and Hyperemic Physiologic Indices
• Actual Study Start Date: Nov 17, 2017
• Anticipated Primary Completion Date: Jan 31, 2019
• Anticipated Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Intravascular Imaging and Physiologic Assessment 330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.	Diagnostic Test: IVUS or OCT and Invasive physiologic indices; IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR) [During Cardiac Cath]

   Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

2. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR) [During Cardiac Cath]

   Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

3. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR) [During Cardiac Cath]

   Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

4. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR) [During Cardiac Cath]

   Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

5. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

   Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

6. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

   Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

7. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

   Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

8. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

   Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

9. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

   Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

10. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

11. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

12. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

13. Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

    Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

14. Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR [During Cardiac Cath]

    Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR ≤0.89

15. Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR [During Cardiac Cath]

    Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR ≤0.89

16. Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

Secondary Outcome Measures

1. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

   Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

2. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

   Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

3. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

   Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

4. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

   Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

5. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

   Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

6. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

   Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

7. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

   Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

8. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

   Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

9. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

   Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

10. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

11. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

12. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

13. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

    Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

14. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

15. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

16. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

17. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

18. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

19. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

20. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

21. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

22. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

23. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

24. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

25. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

26. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

27. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

28. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

29. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR [During Cardiac Cath]

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

30. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR [During Cardiac Cath]

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

31. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR [During Cardiac Cath]

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

32. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR [During Cardiac Cath]

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

33. Linear correlation between percent diameter stenosis and FFR [During Cardiac Cath]

    Linear regression analysis between percent diameter stenosis and FFR

34. Linear correlation between percent diameter stenosis and iFR [During Cardiac Cath]

    Linear regression analysis between percent diameter stenosis and iFR

35. Linear correlation between percent diameter stenosis and dPR [During Cardiac Cath]

    Linear regression analysis between percent diameter stenosis and dPR

36. Linear correlation between percent diameter stenosis and RFR [During Cardiac Cath]

    Linear regression analysis between percent diameter stenosis and RFR

37. Linear correlation between minimal lumen diameter and FFR [During Cardiac Cath]

    Linear regression analysis between minimal lumen diameter and FFR

38. Linear correlation between minimal lumen diameter and iFR [During Cardiac Cath]

    Linear regression analysis between minimal lumen diameter and iFR

39. Linear correlation between minimal lumen diameter and dPR [During Cardiac Cath]

    Linear regression analysis between minimal lumen diameter and dPR

40. Linear correlation between minimal lumen diameter and RFR [During Cardiac Cath]

    Linear regression analysis between minimal lumen diameter and RFR

41. Linear correlation between minimal lumen area and FFR [During Cardiac Cath]

    Linear regression analysis between minimal lumen area and FFR

42. Linear correlation between minimal lumen area and iFR [During Cardiac Cath]

    Linear regression analysis between minimal lumen area and iFR

43. Linear correlation between minimal lumen area and dPR [During Cardiac Cath]

    Linear regression analysis between minimal lumen area and dPR

44. Linear correlation between minimal lumen area and RFR [During Cardiac Cath]

    Linear regression analysis between minimal lumen area and RFR

45. Linear correlation between plaque burden and FFR [During Cardiac Cath]

    Linear regression analysis between plaque burden and FFR

46. Linear correlation between plaque burden and iFR [During Cardiac Cath]

    Linear regression analysis between plaque burden and iFR

47. Linear correlation between plaque burden and dPR [During Cardiac Cath]

    Linear regression analysis between plaque burden and dPR

48. Linear correlation between plaque burden and RFR [During Cardiac Cath]

    Linear regression analysis between plaque burden and RFR

49. Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR [During Cardiac Cath]

    Discriminatory function of percent diameter stenosis to predict functional significance defined by FFR≤0.80

50. Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR [During Cardiac Cath]

    Discriminatory function of percent diameter stenosis to predict functional significance defined by iFR≤0.89

51. Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR [During Cardiac Cath]

    Discriminatory function of percent diameter stenosis to predict functional significance defined by dPR≤0.89

52. Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR [During Cardiac Cath]

    Discriminatory function of percent diameter stenosis to predict functional significance defined by RFR≤0.89

53. Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR [During Cardiac Cath]

    Discriminatory function of minimal lumen diameter to predict functional significance defined by FFR≤0.80

54. Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR [During Cardiac Cath]

    Discriminatory function of minimal lumen diameter to predict functional significance defined by iFR≤0.89

55. Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR [During Cardiac Cath]

    Discriminatory function of minimal lumen diameter to predict functional significance defined by dPR≤0.89

56. Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR [During Cardiac Cath]

    Discriminatory function of minimal lumen diameter to predict functional significance defined by RFR≤0.89

57. Discriminatory function of minimal lumen area to predict functional significance assessed by FFR [During Cardiac Cath]

    Discriminatory function of minimal lumen area to predict functional significance defined by FFR≤0.80

58. Discriminatory function of minimal lumen area to predict functional significance assessed by iFR [During Cardiac Cath]

    Discriminatory function of minimal lumen area to predict functional significance defined by iFR≤0.89

59. Discriminatory function of minimal lumen area to predict functional significance assessed by dPR [During Cardiac Cath]

    Discriminatory function of minimal lumen area to predict functional significance defined by dPR≤0.89

60. Discriminatory function of minimal lumen area to predict functional significance assessed by RFR [During Cardiac Cath]

    Discriminatory function of minimal lumen area to predict functional significance defined by RFR≤0.89

61. Discriminatory function of plaque burden to predict functional significance assessed by FFR [During Cardiac Cath]

    Discriminatory function of plaque burden to predict functional significance defined by FFR≤0.80

62. Discriminatory function of plaque burden to predict functional significance assessed by iFR [During Cardiac Cath]

    Discriminatory function of plaque burden to predict functional significance defined by iFR≤0.89

63. Discriminatory function of plaque burden to predict functional significance assessed by dPR [During Cardiac Cath]

    Discriminatory function of plaque burden to predict functional significance defined by dPR≤0.89

64. Discriminatory function of plaque burden to predict functional significance assessed by RFR [During Cardiac Cath]

    Discriminatory function of plaque burden to predict functional significance defined by RFR≤0.89

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who suspected ischemic heart disease, and underwent invasive physiologic assessment and intravascular ultrasound

Exclusion Criteria:

• Cardiogenic shock

• Graft vessel

• In-stent restenosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351
2	Seoul national university hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital
• Samsung Medical Center

Investigators

• Study Chair: Bon-Kwon Koo, MD, PhD, Professor
• Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03795714
• Other Study ID Numbers: IVUS2017-11-056-001
• First Posted: Jan 8, 2019
• Last Update Posted: Jan 22, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bon-Kwon Koo, Professor, Seoul National University Hospital: Intravascular Ultrasound; Optical Coherence Tomography; Fractional Flow Reserve; Diastolic Pressure Ratio; Resting Full-Cycle Ratio; Ischemic Heart Disease; Instantaneous Wave-free Ratio
• Additional relevant MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease

Study Results

No Results Posted as of Jan 22, 2019