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Integrated Coronary Multicenter Imaging Registry - Extended

Integrated Coronary Multicenter Imaging Registry - Extended

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04153903
Enrollment
200
Registered
2019-11-06
Start date
2019-07-10
Completion date
2025-03-31
Last updated
2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

OTHEROCT, coronary angiography, FFR

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of computed FFR derived by coronary images and real FFR valuesat registrationFFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values

Secondary

MeasureTime frameDescription
Adverse event (Death, acute myocardial infarction)2 years after registrationDeath and occurrence of myocardial infarction during follow-up period will be assessed.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026