Clinical trial NCT03298282: Integrated Coronary Multicenter Imaging Registry
Official title: Integrated Coronary Multicenter Imaging Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary cardiovascular hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of plaque on coronary CTA for during 2 years
timeFrame: at registration
measure: Change of plaque on coronary CTA for during 2 years
timeFrame: at 2-year follow up
measure: Change of plaque on coronary OCT for during 2 years
timeFrame: at registration
measure: Change of plaque on coronary OCT for during 2 years
timeFrame: at 2-year follow up
measure: Change of FFR value during 2 years
timeFrame: at registration
measure: Change of FFR value during 2 years
timeFrame: at 2-year follow up
measure: Comparison of computational FFR derived from OCT to invasive FFR
timeFrame: at registration
measure: Comparison of computational FFR derived from OCT to invasive FFR
timeFrame: at 2-year follow up
Secondary outcomes:
measure: Adverse event for 2 years (myocardial infarction, cardiovascular death)
timeFrame: within 2 years after registration
measure: Power of plaque characteristics on coronary CTA for predicting adverse events
timeFrame: within 2 years after registration
measure: Power of plaque characteristics on OCT for predicting adverse events
timeFrame: within 2 years after registration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Cardiovascular Hospital, Yonsei University
Study officials:
affiliation: Severance Hospital
name: Jung-Sun Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YJ, Kim YW, Ha J, Kim M, Guagliumi G, Granada JF, Lee SG, Lee JJ, Cho YK, Yoon HJ, Lee JH, Kim U, Jang JY, Oh SJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Chang HJ, Ko YG, Choi D, Hong MK, Jang Y, Lee JS, Kim JS. Computational Fractional Flow Reserve From Coronary Computed Tomography Angiography-Optical Coherence Tomography Fusion Images in Assessing Functionally Significant Coronary Stenosis. Front Cardiovasc Med. 2022 Jun 13;9:925414. doi: 10.3389/fcvm.2022.925414. eCollection 2022.