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Integrated Coronary Multicenter Imaging Registry

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ClinicalTrials.gov Identifier: NCT03298282
Recruitment Status : Enrolling by invitation
First Posted : October 2, 2017
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The coronary images of selective angiography and optical coherence tomography 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 (Optical Coherence Tomography) Other: selective CTA Other: FFR

Detailed Description:

The coronary images of selective angiography and optical coherence tomography with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.

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.


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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Coronary Multicenter Imaging Registry
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Imaging Registry
Imaging cohort: Patients with intermediate lesions
Other: OCT (Optical Coherence Tomography)
Coronary images by OCT and selective CTA and FFR values will be registered.

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

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




Primary Outcome Measures :
  1. Comparison of computed FFR derived by OCT [ Time Frame: at registration ]
  2. Comparison of computed FFR derived by selective CTA [ Time Frame: at registration ]
  3. Comparison of computed FFR derived by real FFR values [ Time Frame: at registration ]

Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 2 years after registration ]


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:   Non-Probability Sample
Study Population
Tertiary cardiovascular hospital
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 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

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): NCT03298282


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: NCT03298282     History of Changes
Other Study ID Numbers: 1-2017-0049
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 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