- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153903
Integrated Coronary Multicenter Imaging Registry - Extended
November 3, 2019 updated by: Yonsei University
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03722
- Division of Cardiology, Cardiovascular Hospital, Yonsei University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Coronary artery disease
Description
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 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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
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Coronary images by OCT and angiography and FFR values will be registered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of computed FFR derived by coronary images and real FFR values
Time Frame: at registration
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FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values
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at registration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event (Death, acute myocardial infarction)
Time Frame: 2 years after registration
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Death and occurrence of myocardial infarction during follow-up period will be assessed.
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2 years after registration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2019
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
March 1, 2025
Study Registration Dates
First Submitted
November 3, 2019
First Submitted That Met QC Criteria
November 3, 2019
First Posted (Actual)
November 6, 2019
Study Record Updates
Last Update Posted (Actual)
November 6, 2019
Last Update Submitted That Met QC Criteria
November 3, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2019-0476
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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