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Coronary Microvascular Function and CT Coronary Angiography (CorCTCA)

Study acronym: CorCTCA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 20, 2022 to Dec 20, 2023
    • Study completion date: Aug 31, 2031 to Aug 31, 2033
    • Publications: details revised at 1 of 17 entries
    v5
  2. Primary completion date: Dec 20, 2021 to Dec 20, 2022v4
  3. Primary completion date: Aug 31, 2020 to Dec 20, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 31, 2021 to Aug 31, 2031
    • Site details revised at 3 of 3 sites
    v3
  4. Publications: 13 to 17v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Angina in patients without obstructive coronary artery disease (CAD) is a clinical conundrum and patient management is heterogeneous. Hypothesis: Abnormal coronary function is common and clinically relevant in this population. Design: An observational cohort study and nested randomised controlled diagnostic strategy trial. Methods: 250 patients with known or suspected angina informed by validated questionnaires but without obstructive CAD (\<70% stenosis) in an artery \>=2.5 mm or structural heart disease, as revealed by CT coronary angiography (CTCA), will be invited to undergo coronary function testing (FFR, CFR, IMR; intra-coronary ACh) during invasive angiography. Patients will be randomised following angiography but before testing coronary function to disclosure of the coronary function test results or not. Treatment decisions by the attending cardiologist will be recorded before and after disclosure of results. Outcomes: Primary: The between-group difference in the reclassification rate of the initial diagnosis using logistic regression, adjusted for baseline factors associated with the likelihood of reclassification of the initial diagnosis. Secondary: Prevalence of microvascular or vasospastic angina; health status reflected by the EuroQol group 5-Dimensions (EQ-5D), Seattle Angina Questionnaire, Illness perception, treatment satisfaction questionnaires and functional status questionnaires; angina medication and adherence. Value: This research will provide new insights into the conundrum of angina in patients without obstructive CAD or structural heart disease.
Trial Details
NCT Number NCT03477890
Lead Sponsor NHS National Waiting Times Centre Board
Collaborators: University of Glasgow, British Heart Foundation, Chief Scientist Office of the Scottish Government, NHS Greater Clyde and Glasgow
Conditions
(from sponsor)		 Angina, Stable, Angina Pectoris, Variant, Microvascular Angina
Related terms Angina Pectoris, Variant, Angina, Stable, Microvascular Angina
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov