Integrated Coronary Multicenter Imaging Registry - Extended

Coronary Artery Disease Clinical Trial

Official title:

Integrated Coronary Multicenter Imaging Registry - Extended

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04153903
• Other study ID #: 4-2019-0476
• Status: Enrolling by invitation
• Start date: July 10, 2019
• Est. completion date: March 2025

Study information

• Verified date: November 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• OCT, coronary angiography, FFR
Coronary images by OCT and angiography 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	Comparison of computed FFR derived by coronary images and real FFR values	FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values	at registration
Secondary	Adverse event (Death, acute myocardial infarction)	Death and occurrence of myocardial infarction during follow-up period will be assessed.	2 years after registration