Integrated Coronary Multicenter Imaging Registry - Extended

NCT04153903 | Unknown

• 1 other identifier: 4-2019-0476
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse event (Death, acute myocardial infarction)

  2 years after registration

Study Arms (1)

Patients with intermediate lesions

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)

Other: OCT, coronary angiography, FFR

Interventions

OCT, coronary angiography, FFR OTHER

Coronary images by OCT and angiography and FFR values will be registered.

Patients with intermediate lesions

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Coronary artery disease

You may qualify if:

• 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 50-70%)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Cardiovascular Hospital, Yonsei University

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 6, 2019
• Study Start: July 10, 2019
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)