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Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Function and CT Coronary Angiogram (CorCTCA) study.

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.

SUBMITTER: Sidik NP

PROVIDER: S-EPMC7029345 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Function and CT Coronary Angiogram (CorCTCA) study.

Sidik Novalia P NP McEntegart Margaret M Roditi Giles G Ford Thomas J TJ McDermott Michael M Morrow Andrew A Byrne John J Adams Jacqueline J Hargreaves Allister A Oldroyd Keith G KG Stobo David D Wu Olivia O Messow Claudia-Martina CM McConnachie Alex A Berry Colin C

American heart journal 20191202

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).<h4>Objectives</h4>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.<h4>Design</h4>A prospective, multicenter, randomized, blinded, sham-controlled trial of stratified medicine (NCT03477890) will be per ...[more]

PMID: 31911341

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Project description:BACKGROUND:Coronary angiography is performed to assess for obstructive coronary artery disease (CAD), but "nonobstructive CAD" is a common finding. Microvascular or vasospastic angina may be relevant, but routine confirmatory testing is not evidence based and thus rarely performed. AIM:The aim was to assess the effect of stratified medicine guided by coronary function testing on the diagnosis, treatment, and well-being of patients with angina and nonobstructive CAD. DESIGN:The BHF CorMicA trial is a prospective, multicenter, randomized, blinded, sham-controlled trial of stratified medicine (NCT03193294). All-comers referred for elective coronary angiography for investigation of suspected CAD will be screened. Following informed consent, eligible patients with angina and nonobstructive CAD will be randomized 1:1 immediately in the catheter laboratory to either coronary artery function-guided diagnosis and treatment (intervention group) or not (control group). Coronary function will be assessed using a pressure-temperature-sensitive guidewire and adenosine followed by pharmacological testing with intracoronary acetylcholine. Patients will be stratified into endotypes with linked therapy. The primary outcome is change in Seattle Angina Questionnaire score at 6 months. Secondary outcomes include safety, feasibility, diagnostic utility (impact on diagnosis and diagnostic certainty), and clinical utility (impact on treatment and investigations). Health status is a key secondary outcome assessed according to the following domains: quality of life, treatment satisfaction, illness perception, physical activity, and anxiety-depression score. Patients with obstructive disease who are not randomized will form a registry group who will be followed up as a comparator for secondary outcomes including health status. Health and economic outcomes will be evaluated in the longer term using electronic health record linkage. VALUE:CorMicA is a proof-of-concept clinical trial of a disruptive stratified intervention with potential benefits to patients and health care providers.

Project description:Background and purposeIn acute middle cerebral artery (MCA) stroke, CT angiographic (CTA) source images (CTA-SI) identify tissue likely to infarct despite early recanalization. This pilot study evaluated the impact of recanalization status on clinical and radiologic predictors of patient outcomes.Materials and methodsOf 44 patients undergoing CT/CTA within 6 hours of developing symptoms of proximal MCA ischemia, 19 patients achieved complete proximal MCA (MCA M1) recanalization. Admission National Institutes of Health Stroke Scale (NIHSS) score, onset-to-imaging time, CTA-SI Alberta Stroke Program Early CT Score, MCA M1 occlusion, cerebrovascular collaterals score, and CTA-SI lesion volume were correlated with 3- to 6-month follow-up modified Rankin Scale (mRS). We developed 2 stepwise regression models: one for patients with complete MCA M1 recanalization and one for patients without complete recanalization.ResultsComplete and incomplete recanalization groups had similar median admission NIHSS scores (19 versus 19) and mean onset-to-imaging times (2.3 versus 1.9 hours) but different proportions of patients achieving mRS scores 0-2 (74% versus 40%; P = .04). The only independent predictors of clinical outcome in patients with complete recanalization were onset-to-imaging time and admission CTA-SI lesion volume (total model R(2) = 0.75; P = .01). The only independent predictors of outcome in patients with incomplete recanalization were admission CTA-SI lesion volume and NIHSS score (total model R(2) = 0.66; P = .007).ConclusionRegardless of recanalization status, admission CTA-SI lesion volume was associated with clinical outcome. Recanalization status did, however, affect which variables in addition to CTA-SI volume significantly impacted clinical outcome: time with complete recanalization and NIHSS with incomplete recanalization. This finding may support the development of a model predicting the potential clinical benefit expected with early successful recanalization.

Project description:Objectives- Coronary endothelial dysfunction is a precursor of atherosclerosis and adverse outcomes. Whether endothelial dysfunction is a localized or generalized phenomenon in humans remains uncertain. We simultaneously measured femoral and coronary vascular function with the hypothesis that peripheral vascular endothelial function will be reflective of coronary endothelial function. Approach and Results- Eighty-five subjects underwent coronary angiography for evaluation of chest pain or abnormal stress tests. Endothelium-dependent and -independent vascular function were measured using intracoronary and intrafemoral infusions of acetylcholine and sodium nitroprusside, respectively. Coronary flow reserve was assessed using intracoronary adenosine infusion. Flow velocity was measured in each circulation using a Doppler wire (FloWire, EndoSonics). Coronary vascular resistance and femoral vascular resistance were calculated as mean arterial pressure (mm Hg)/coronary blood flow (mL/min) and mean arterial pressure (mm Hg)/femoral average peak velocity (cm/s), respectively. Mean age was 53±11 years, 37% were female, 44% had hypertension, 12% had diabetes mellitus, and 38% had obstructive coronary artery disease. There was a correlation between the change in femoral vascular resistance with acetylcholine and acetylcholine-mediated changes in both the coronary vascular resistance ( r=0.27; P=0.014) and in the epicardial coronary artery diameter ( r=-0.25; P=0.021), indicating that subjects with normal endothelial function in the femoral circulation had normal endothelial function in the coronary epicardial and microcirculation and vice versa. The coronary vasodilator response to adenosine also correlated with the femoral vasodilatation with acetylcholine ( r=0.4; P=0.0002). There was no correlation between the coronary and femoral responses to sodium nitroprusside. Conclusions- Endothelial functional changes in the peripheral and coronary circulations were modestly correlated. Thus, peripheral microvascular endothelial function reflects endothelium-dependent coronary epicardial and microvascular function and the coronary flow reserve. Visual Overview- An online visual overview is available for this article.

Project description:ObjectivesThis study compared the accuracy of an automated, vessel-specific minimum cost path (MCP) myocardial perfusion territory assignment technique as compared with the standard American Heart Association 17-segment (AHA) model.MethodsSix swine (42 ± 9 kg) were used to evaluate the accuracy of the MCP technique and the AHA method. In each swine, a dynamic acquisition, comprised of twenty consecutive whole heart volume scans, was acquired with a computed tomography scanner, following peripheral injection of contrast material. From this acquisition, MCP and AHA perfusion territories were determined, for the left (LCA) and right (RCA) coronary arteries. Each animal underwent additional dynamic acquisitions, consisting of twenty consecutive volume scans, following direct intracoronary contrast injection into the LCA or RCA. These images were used as the reference standard (REF) LCA and RCA perfusion territories. The MCP and AHA techniques' perfusion territories were then quantitatively compared with the REF perfusion territories.ResultsThe myocardial mass of MCP perfusion territories (MMCP) was related to the mass of reference standard perfusion territories (MREF) by MMCP = 0.99MREF + 0.39 g (r = 1.00; R2 = 1.00). The mass of AHA perfusion territories (MAHA) was related to MREF by MAHA = 0.81MREF + 5.03 g (r = 0.99; R2 = 0.98).ConclusionThe vessel-specific MCP myocardial perfusion territory assignment technique more accurately quantifies LCA and RCA perfusion territories as compared with the current standard AHA 17-segment model. Therefore, it can potentially provide a more comprehensive and patient-specific evaluation of coronary artery disease.Key points• The minimum cost path (MCP) technique accurately determines left and right coronary artery perfusion territories, as compared with the American Heart Association 17-segment (AHA) model. • The minimum cost path (MCP) technique could be applied to cardiac computed-tomography angiography images to accurately determine patient-specific left and right coronary artery perfusion territories. • The American Heart Association 17-segment (AHA) model often fails to accurately determine left and right coronary artery perfusion territories, especially in the inferior and inferoseptal walls of the left ventricular myocardium.

Dataset Information

Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Function and CT Coronary Angiogram (CorCTCA) study.

Publications

Rationale and design of the British Heart Foundation (BHF) Coronary Microvascular Function and CT Coronary Angiogram (CorCTCA) study.

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