Integrated Coronary Multicenter Imaging Registry

Study Overview
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Brief Summary
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The coronary images of selective angiography and optical coherence tomography with FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be prospectively registered.

Detailed Description
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The patients with intermediate lesions after CT angiography and invasive coronary angiography will be screened, and optical coherence tomography, FFR and selective CT angiography will be performed. The coronary images and FFR values will be registered, and the patients will be followed-up up to 2 years to investigate the adverse clinical events.

Official Title
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Integrated Coronary Multicenter Imaging Registry

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: OCT (Optical Coherence Tomography)
* Other: Coronary CTA
* Other: FFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent coronary CT angiography because of chest pain Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 40-70%) Age: 20-80 yrs Patients who consent and fully understand the protocol Patients who consent the clinical follow-up Patients who can be followed-up Exclusion Criteria: Patients who had contrast allergy Patients who had unstable blood pressure needing the vasopressors Patients who had severe left ventricular function (left ventricular ejection fraction<30%) Chronic kidney disease who had Cr level of greater than 2.0 mg/dl Patients whose expected survival is less than 12 months Patients who had a severe valvular disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Imaging Registry<br>Imaging cohort: Patients with intermediate lesions | Other: OCT (Optical Coherence Tomography)<br>* Coronary images by OCT and selective CTA and FFR values will be registered.<br>Other: Coronary CTA<br>* Coronary images by OCT and Coronary CTA and FFR values will be registered.<br>Other: FFR<br>* Coronary images by OCT and selective CTA and FFR values will be registered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of plaque on coronary CTA for during 2 years |  | at registration | 
| Change of plaque on coronary CTA for during 2 years |  | at 2-year follow up | 
| Change of plaque on coronary OCT for during 2 years |  | at registration | 
| Change of plaque on coronary OCT for during 2 years |  | at 2-year follow up | 
| Change of FFR value during 2 years |  | at registration | 
| Change of FFR value during 2 years |  | at 2-year follow up | 
| Comparison of computational FFR derived from OCT to invasive FFR |  | at registration | 
| Comparison of computational FFR derived from OCT to invasive FFR |  | at 2-year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event for 2 years (myocardial infarction, cardiovascular death) |  | within 2 years after registration | 
| Power of plaque characteristics on coronary CTA for predicting adverse events |  | within 2 years after registration | 
| Power of plaque characteristics on OCT for predicting adverse events |  | within 2 years after registration |