Imaging and Physiologic Evaluation of Coronary Artery Disease

Study Overview
=================
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.

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.

Official Title
-----------------
Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)

Conditions
-----------------
Ischemic Heart Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment
* Procedure: PCI


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICA<br>Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment | Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment<br>* Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment<br>|
| PCI<br>Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment | Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment<br>* Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment<br>Procedure: PCI<br>* Patients who undergoing PCI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | a composite of all-cause death, myocardial infarction, or any revascularization | 3-Year after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause death | death from any-cause | 3-Year after the index procedure | 
| Rate of cardiac death | death from cardiac-cause | 3-Year after the index procedure | 
| Rate of myocardial infarction | Myocardial infarction without peri-procedural myocardial infarction | 3-Year after the index procedure | 
| Rate of target lesion revascularization | ischemia-driven or all | 3-Year after the index procedure | 
| Rate of target vessel revascularization | ischemia-driven or all | 3-Year after the index procedure | 
| Rate of any revascularization | ischemia-driven or all | 3-Year after the index procedure | 
| Rate of stent thrombosis | definite or probable | 3-Year after the index procedure | 
| Rate of ischemic or hemorrhagic stroke | Ischemic or hemorrhagic stoke by braing imaging | 3-Year after the index procedure | 
| Rate of BARC type 2,3, or 5 bleeding | Bleeding Academic Research Consortium (BARC) type 2,3 or 5 bleeding | 3-Year after the index procedure | 
| MACCE | a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke | 3-Year after the index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous Coronary Intervention, Intravascular Imaging, Intravascular Ultrasound, Optical Coherence Tomography, Fractional flow reserve