Integrated Coronary Multicenter Imaging Registry

Coronary Artery Disease Clinical Trial

Official title:

Integrated Coronary Multicenter Imaging Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03298282
• Other study ID #: 1-2017-0049
• Status: Enrolling by invitation
• Start date: October 10, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: September 30, 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• OCT (Optical Coherence Tomography)
Coronary images by OCT and selective CTA and FFR values will be registered.
• Coronary CTA
Coronary images by OCT and Coronary CTA and FFR values will be registered.
• FFR
Coronary images by OCT and selective CTA and FFR values will be registered.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Cardiovascular Hospital, Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of plaque on coronary CTA for during 2 years		at registration
Primary	Change of plaque on coronary CTA for during 2 years		at 2-year follow up
Primary	Change of plaque on coronary OCT for during 2 years		at registration
Primary	Change of plaque on coronary OCT for during 2 years		at 2-year follow up
Primary	Change of FFR value during 2 years		at registration
Primary	Change of FFR value during 2 years		at 2-year follow up
Primary	Comparison of computational FFR derived from OCT to invasive FFR		at registration
Primary	Comparison of computational FFR derived from OCT to invasive FFR		at 2-year follow up
Secondary	Adverse event for 2 years (myocardial infarction, cardiovascular death)		within 2 years after registration
Secondary	Power of plaque characteristics on coronary CTA for predicting adverse events		within 2 years after registration
Secondary	Power of plaque characteristics on OCT for predicting adverse events		within 2 years after registration