Integrated Coronary Multicenter Imaging Registry

• Conditions: Coronary Artery Disease
• Interventions: Other: OCT (Optical Coherence Tomography); Other: Coronary CTA; Other: FFR

• Registration Number: NCT03298282
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-02
• Study Start: 2017-10-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-11
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-09
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Imaging Registry	FFR	Imaging cohort: Patients with intermediate lesions
Imaging Registry	OCT (Optical Coherence Tomography)	Imaging cohort: Patients with intermediate lesions
Imaging Registry	Coronary CTA	Imaging cohort: Patients with intermediate lesions

Primary Outcome Measures

Name	Time	Method
Change of plaque on coronary OCT for during 2 years	at 2-year follow up
Comparison of computational FFR derived from OCT to invasive FFR	at 2-year follow up
Change of plaque on coronary CTA for during 2 years	at 2-year follow up
Change of FFR value during 2 years	at 2-year follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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