Imaging and Physiologic Evaluation of Coronary Artery Disease
Study Details
Study Description
Brief Summary
To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (CAD) undergoing invasive coronary angiography (ICA), intravascular imaging, or invasive physiologic assessment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The traditional standard method for evaluating coronary artery disease (CAD) is invasive coronary angiography (ICA). ICA enables the assessment of anatomic severity of the epicardial artery and the severity of diameter stenosis can be closely associated with myocardial ischemia. However, there remains concern that anatomical severity is not always identical with functional significance. Actually, even the patients showed positive non-invasive tests including treadmill test, stress echocardiography, coronary computed tomography angiography, or nuclear imaging, less than half of the patients showed significant stenosis on ICA. Therefore, the investigators need further investigation to overcome the limitations of ICA.
In this regard, intravascular imaging, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT), is a useful tool for assessing the anatomical severity in more detail. Those imaging modalities produce cross-sectional images of CAD and imaging modalities are allowing to assess lesion characteristics, plaque morphology, treatment planning, and optimization of the implanted stent. Furthermore, imaging-guided percutaneous coronary intervention (PCI) has been shown favorable outcomes, compared with angiography only-guided PCI, especially in complex lesions. Meanwhile, there has been an ample body of evidence that invasive coronary physiology assessment, such as fractional flow reserve (FFR), also can be useful for assessing the functional significance. Therefore, the current guidelines have continuously recommended intracoronary imaging and invasive physiologic assessment for guiding the treatment of CAD.
The aim of the IP-CAD (Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study) is to evaluate the long-term clinical outcomes according to the imaging-guided or physiology-guided PCI in real-world practice.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ICA Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment |
Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment
Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment
|
| PCI Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment |
Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment
Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment
Procedure: PCI
Patients who undergoing PCI
|
Outcome Measures
Primary Outcome Measures
- MACE [3-Year after the index procedure]
a composite of all-cause death, myocardial infarction, or any revascularization
Secondary Outcome Measures
- Rate of all-cause death [3-Year after the index procedure]
death from any-cause
- Rate of cardiac death [3-Year after the index procedure]
death from cardiac-cause
- Rate of myocardial infarction [3-Year after the index procedure]
Myocardial infarction without peri-procedural myocardial infarction
- Rate of target lesion revascularization [3-Year after the index procedure]
ischemia-driven or all
- Rate of target vessel revascularization [3-Year after the index procedure]
ischemia-driven or all
- Rate of any revascularization [3-Year after the index procedure]
ischemia-driven or all
- Rate of stent thrombosis [3-Year after the index procedure]
definite or probable
- Rate of ischemic or hemorrhagic stroke [3-Year after the index procedure]
Ischemic or hemorrhagic stoke by braing imaging
- Rate of BARC type 2,3, or 5 bleeding [3-Year after the index procedure]
Bleeding Academic Research Consortium (BARC) type 2,3 or 5 bleeding
- MACCE [3-Year after the index procedure]
a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must be at least 18 years of age
-
Subjects who suspected ischemic heart disease and underwent ICA.
-
Subjects who were performed intravascular imaging or invasive physiologic assessment
Exclusion Criteria:
-
Subject with Age <18 years
-
Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chonnam National University Hospital | Gwangju | Korea, Republic of | 61469 |
Sponsors and Collaborators
- Chonnam National University Hospital
Investigators
- Principal Investigator: Young Joon LeeHong, MD, PhD, Chonnam National University Medical School; Chonnam National University Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- CNUH-2021-314