Clinical Research Directory
Browse clinical research sites, groups, and studies.
Coronary Microvascular Function and CT Coronary Angiography (CorCTCA)
Sponsor: NHS National Waiting Times Centre Board
Summary
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.
Official title: Angina in Patients Without Obstructive Coronary Disease as Revealed by CT Coronary Angiography (Cor-CTCA): an Observational Cohort Study Involving Coronary Function Tests and a Nested Randomised Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2017-08-31
Completion Date
2033-08-31
Last Updated
2024-10-29
Healthy Volunteers
No
Interventions
Stratified medicine involving a diagnostic intervention
Adjunctive tests of coronary artery lesion severity (fractional flow reserve) and function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with obstructive coronary artery disease (mis-classified by non-invasive CTCA) or no-obstructive coronary disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results). Medical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013), Scottish Intercollegiate Guideline Network (SIGN), 2017).
Stratified medicine involving a diagnostic intervention
Adjunctive tests of coronary artery lesion severity (fractional flow reserve) and function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with obstructive coronary artery disease (mis-classified by non-invasive CTCA) or non-obstructive coronary disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results). Medical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013), Scottish Intercollegiate Guideline Network (SIGN), 2017).
Locations (3)
Golden Jubilee National Hospital
Clydebank, Dunbartonshire, United Kingdom
Forth Valley Royal Hospital
Larbert, Forth Valley, United Kingdom
Glasgow Royal Infirmary
Glasgow, Strathclyde, United Kingdom