Dynamic CT Perfusion for Functional Assessment of Coronary Artery Disease
Study Details
Study Description
Brief Summary
The objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac CT perfusion (CTP) imaging for non-invasive functional assessment of coronary artery disease (CAD). The proposed CTP technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (FFR) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with CAD. The CTP results will be compared with invasive coronary angiography / FFR assessment and non-invasive cardiac magnetic resonance imaging (CMR) / radionuclide perfusion assessment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with coronary artery disease and hemodynamically stable
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Diagnostic Test: Dynamic cardiac CT perfusion imaging
Multiple images of the heart are acquired with a clinical CT scanner after an intravenous bolus injection of contrast solution. The images are then analyzed to provide fractional flow reserve and myocardial perfusion values.
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Outcome Measures
Primary Outcome Measures
- Accuracy of myocardial perfusion obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis [Within 4 weeks prior to invasive cardiac catheterization]
Comparison with invasive coronary angiography and FFR assessment
- Accuracy of FFR obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis [Within 4 weeks prior to invasive cardiac catheterization]
Comparison with invasive coronary angiography and FFR assessment
- Accuracy of combined myocardial perfusion and FFR measurement obtained from dynamic cardiac CT perfusion imaging for detecting functionally significant coronary artery stenosis [Within 4 weeks prior to invasive cardiac catheterization]
Comparison with invasive coronary angiography and FFR assessment
- Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and static CT perfusion [Within 4 weeks prior to invasive cardiac catheterization]
Comparison in patients with multi-vessel CAD where balanced ischemia is expected
- Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and CT-FFR (based on computational fluid dynamics simulation) [Within 4 weeks prior to invasive cardiac catheterization]
Comparison in patients with dense coronary calcification
Secondary Outcome Measures
- Comparison of diagnostic accuracy for functional CAD assessment between dynamic CT perfusion and other non-CT perfusion imaging techniques [Within 4 weeks of the acquisition of non-CT perfusion imaging]
Comparison with CMR / radionuclide perfusion assessment
- Comparison of diagnostic accuracy of dynamic CT perfusion for functional CAD assessment between male and female patients [Within 4 weeks prior to invasive cardiac catheterization]
Sex-based analysis
Eligibility Criteria
Criteria
- Subject Inclusion Criteria
Patients need to meet all the following inclusion criteria to be enrolled in the study:
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Symptomatic and hemodynamically stable
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Acute coronary syndrome (ACS) ruled out based on absence of abnormal changes in ECG and cardiac enzymes
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Referral for cardiac catheterization based on clinical history and non-invasive imaging test findings. Non-invasive imaging findings include one or more of the following: (i) Evidence of myocardial ischemia from radionuclide myocardial perfusion imaging; (ii) Evidence of myocardial ischemia from CMR myocardial perfusion imaging; (iii) Evidence of ≥ 50% stenosis in the left circumflex artery (LCx), left anterior descending artery (LAD) and/or right coronary artery (RCA) from CCTA.
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Ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator)
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Written informed consent
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Subject Exclusion Criteria
Patients meeting at least one of the following criteria will be excluded from the study:
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Recent (< 1 month) ACS
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CCTA reveals ≥ 50% stenosis in the left main artery
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Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
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Contraindications to stress perfusion imaging, including: i) severe reactive airway disease; ii) high-grade atrioventricular block; iii) allergy to vasodilators; iv) caffeine within 12 hours; v) theophylline use within 48 hours.
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History of CABG surgery
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History of malignancy during the past 3 years prior to screening
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History of alcohol and/or drug abuse within 3 years prior to screening
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Sign of pregnancy
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Pregnant or nursing
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History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents
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Recent (< 1 month) use of an investigational drug or device
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Participation in any other investigational drug or device trial during the conduct of this study
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Lack of ability or willingness to comply with the protocol requirements or deemed by the Site Investigator to be unfit for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Joseph's Hospital | London | Ontario | Canada | N6A 4V2 |
Sponsors and Collaborators
- Lawson Health Research Institute
- Canadian Institutes of Health Research (CIHR)
- London Health Sciences Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12052020