Coronary Artery DiseaseNCT04153903
Integrated Coronary Multicenter Imaging Registry - Extended
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OCT, coronary angiography, FFR
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2019to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary artery disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Cardiovascular Hospital, Yonsei University
Seoul, 03722
About this study
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
- Being tested
- OCT, coronary angiography, FFR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT, coronary angiography, FFROther
Coronary images by OCT and angiography and FFR values will be registered.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: OCT, coronary angiography, FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at registration
Secondary outcomes (1)
Adverse event (Death, acute myocardial infarction)
Death and occurrence of myocardial infarction during follow-up period will be assessed.
Measured: 2 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start10 Jul 2019
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153903
- Sponsor's protocol ID
- 4-2019-0476
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Coronary Multicenter Imaging Registry - Extended
- ClinicalTrials.gov ID
- NCT04153903
- Acronym / sponsor ID
- 4-2019-0476
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intermediate lesions | – | Other: OCT, coronary angiography, FFRImaging 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) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary artery disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT, coronary angiography, FFRCoronary images by OCT and angiography and FFR values will be registered. | Other | Patients with intermediate lesions |
Primary outcome
Comparison of computed FFR derived by coronary images and real FFR values
Time frame: at registration
FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values
1 secondary outcome
Adverse event (Death, acute myocardial infarction)
Time frame: 2 years after registration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of computed FFR derived by coronary images and real FFR values (time frame: at registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.