Integrated Coronary Multicenter Imaging Registry - Extended

• Conditions: Coronary Artery Disease
• Interventions: Other: OCT, coronary angiography, FFR

• Registration Number: NCT04153903
• Lead Sponsor: Yonsei University

Brief Summary

The coronary images of invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-10
• Status Verified: 2019-11
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-03
• Last Update Submitted: 2019-11-03
• Study First Posted: 2019-11-06
• Last Update Posted: 2019-11-06
• Primary Completion: 2024-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who underwent coronary CT angiography because of chest pain
2. Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 50-70%)
3. Age: 20-80 yrs
4. Patients who consent and fully understand the protocol
5. Patients who consent the clinical follow-up
6. Patients who can be followed-up

Exclusion Criteria

1. Patients who had contrast allergy
2. Patients who had unstable blood pressure needing the vasopressors
3. Patients who had severe left ventricular function (left ventricular ejection fraction<30%)
4. Chronic kidney disease who had Cr level of greater than 2.0 mg/dl
5. Patients whose expected survival is less than 12 months
6. Patients who had a severe valvular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with intermediate lesions	OCT, coronary angiography, FFR	Imaging cohort will be performed invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis)

Primary Outcome Measures

Name	Time	Method
Comparison of computed FFR derived by coronary images and real FFR values	at registration	FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values

Secondary Outcome Measures

Name	Time	Method
Adverse event (Death, acute myocardial infarction)	2 years after registration	Death and occurrence of myocardial infarction during follow-up period will be assessed.

Trial Locations

Locations (1)

Division of Cardiology, Cardiovascular Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of