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Integrated Coronary Multicenter Imaging Registry

Integrated Coronary Multicenter Imaging Registry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03298282
Enrollment
180
Registered
2017-10-02
Start date
2017-10-10
Completion date
2021-09-30
Last updated
2020-10-19

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 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.

Interventions

Coronary images by OCT and selective CTA and FFR values will be registered.

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

OTHERFFR

Coronary images by OCT and selective CTA 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

* 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

Design outcomes

Primary

MeasureTime frame
Change of plaque on coronary CTA for during 2 yearsat registration
Change of plaque on coronary OCT for during 2 yearsat registration
Change of FFR value during 2 yearsat registration
Comparison of computational FFR derived from OCT to invasive FFRat registration

Secondary

MeasureTime frame
Power of plaque characteristics on coronary CTA for predicting adverse eventswithin 2 years after registration
Power of plaque characteristics on OCT for predicting adverse eventswithin 2 years after registration
Adverse event for 2 years (myocardial infarction, cardiovascular death)within 2 years after registration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026