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Integrated Coronary Multicenter Imaging Registry - Extended

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ClinicalTrials.gov Identifier: NCT04153903
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Other: OCT, coronary angiography, FFR

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Coronary Multicenter Imaging Registry - Extended
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2025

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)
Other: OCT, coronary angiography, FFR
Coronary images by OCT and angiography and FFR values will be registered.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse event (Death, acute myocardial infarction) [ Time Frame: 2 years after registration ]
    Death and occurrence of myocardial infarction during follow-up period will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Coronary artery disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153903


Locations
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Korea, Republic of
Division of Cardiology, Cardiovascular Hospital, Yonsei University
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04153903     History of Changes
Other Study ID Numbers: 4-2019-0476
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases