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Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Function and CT Coronary Angiogram
Novalia P Sidik1, Margaret McEntegart1, Giles Roditi2
1West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Insights
This study investigates microvascular and vasospastic anginas in patients with ischemia with no obstructive coronary artery disease (INOCA) after CTCA. It aims to diagnose disease endotypes and assess the value of stratified medicine for improved angina management.
Area of Science:
- Cardiology
- Diagnostic Imaging
- Clinical Trials
Background:
- Microvascular and vasospastic anginas are key causes of ischemia with no obstructive coronary artery disease (INOCA).
- Computed tomography coronary angiography (CTCA) is used to investigate suspected coronary artery disease (CAD).
- Accurate diagnosis of INOCA endotypes is crucial for effective treatment.
Purpose of the Study:
- To characterize the prevalence of INOCA disease endotypes.
- To determine the clinical value of stratified medicine in INOCA patients.
- To improve diagnostic accuracy and treatment strategies for angina.
Main Methods:
- Prospective, multicenter, randomized, blinded, sham-controlled trial (NCT03477890).
- Invasive diagnostic procedures (IDP) including coronary angiography and acetylcholine provocation tests to identify endotypes.
- Randomization to stratified medicine or standard care, with outcomes assessed using the Seattle Angina Questionnaire.
Main Results:
- The study will characterize the prevalence of specific INOCA disease endotypes.
- It will evaluate the impact of stratified medicine on patient-reported outcomes.
- Diagnostic utility and clinical utility of the stratified approach will be assessed.
Conclusions:
- Stratified medicine holds promise for optimizing treatment in INOCA patients.
- Accurate endotype diagnosis is essential for personalized angina management.
- This research will provide valuable insights into the clinical utility of stratified medicine for INOCA.
Abstract:
Microvascular and/or vasospastic anginas are relevant causes of ischemia with no obstructive coronary artery disease (INOCA) in patients after computed tomography coronary angiography (CTCA).
Objectives:
Our research has 2 objectives. The first is to undertake a diagnostic study, and the second is to undertake a nested, clinical trial of stratified medicine.
Design:
A prospective, multicenter, randomized, blinded, sham-controlled trial of stratified medicine (NCT03477890) will be performed. All-comers referred for clinically indicated CTCA for investigation of suspected coronary artery disease (CAD) will be screened in 3 regional centers. Following informed consent, eligible patients with angina symptoms are enrolled before CTCA and remain eligible if CTCA excludes obstructive CAD. Diagnostic study: Invasive coronary angiography involving an interventional diagnostic procedure (IDP) to assess for disease endotypes: (1) angina due to obstructive CAD (fractional flow reserve ≤0.80); (2) microvascular angina (coronary flow reserve <2.0 and/or index of microvascular resistance >25); (3) microvascular angina due to small vessel spasm (acetylcholine); (4) vasospastic angina due to epicardial coronary spasm (acetylcholine); and (5) noncoronary etiology (normal coronary function). The IDP involves direct invasive measurements using a diagnostic coronary guidewire followed by provocation testing with intracoronary acetylcholine. The primary outcome of the diagnostic study is the reclassification of the initial CTCA diagnosis based on the IDP. Stratified medicine trial: Participants are immediately randomized 1:1 in the catheter laboratory to therapy stratified by endotype (intervention group) or not (control group). The primary outcome of the trial is the mean within-subject change in Seattle Angina Questionnaire score at 6 months. Secondary outcomes include safety, feasibility, diagnostic utility (impact on diagnosis and certainty), and clinical utility (impact on treatment and investigations). Health status assessments include quality of life, illness perception, anxiety-depression score, treatment satisfaction, and physical activity. Participants who are not randomized will enter a follow-up registry. Health and economic outcomes in the longer term will be assessed using electronic patient record linkage.
Value:
CorCTCA will prospectively characterize the prevalence of disease endotypes in INOCA and determine the clinical value of stratified medicine in this population.
