The iCorMicA study is a multicentre, prospective, randomised, double-blind, sham-controlled, parallel-group, end-point trial and registry. The investigators seek to determine whether stratified medical therapy guided by an adjunctive interventional diagnostic procedure (IDP) during the invasive management of patients with known or suspected angina but no obstructive coronary artery disease improves symptoms, wellbeing, cardiovascular risk and clinical outcomes.
Age ≥18 years.
A clinical plan for invasive coronary angiography.
Symptoms of angina (typical or atypical) according to the Rose- and/or Seattle Angina questionnaires.
Able to comply with study procedures.
A non-coronary primary indication for invasive angiography (e.g. valve disease, heart failure).
History of coronary artery bypass surgery.
Presence of obstructive disease evident in a main coronary artery (diameter >2.5 mm), i.e. a coronary stenosis >50% and/or a fractional flow reserve (FFR) ≤0.80*.
Logistical reason*. *These patients will enter a follow-up registry.
Parallel
Disclosure of IDP results
Diagnostic testThe results of the adjunctive IDP performed at time of invasive coronary angiography are made available to the catheter laboratory clinician, to aid in the diagnostic process.
IDP performed but results not disclosed
Other interventionThe results of the IDP performed at the time of invasive coronary angiography are concealed from the catheter laboratory clinician who will be blinded. The patient is managed according to standard of care.
Seattle Angina Questionnaire (SAQ) Summary Score
The 7-item version of the SAQ reflects the frequency of angina (SAQ Angina Frequency score) and the disease-specific effect of angina on patients' physical function (SAQ Physical Limitation score) and quality of life (Quality of Life score) over the previous 4 weeks; these scores are averaged to obtain the SAQ Summary score, which is an overall measure of patients' stable ischaemic heart disease-specific health status. SAQ scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life.
Feasibility of stratified medicine
Rates of enrolment, drop-out, completion of diagnostic protocol, integrity of blinding in the catheter laboratory and blinding at 1 year, loss to follow-up.
Safety of the interventional diagnostic procedure (IDP)
As reflected by SAEs related to the procedure, and those arising during longer term follow-up.
Diagnostic utility of the interventional diagnostic procedure (IDP)
To assess impact of disclosure of the coronary function test results on the diagnosis and certainty of the diagnosis. A missed diagnosis of microvascular angina is defined as a physician diagnosis of non-cardiac chest pain in the presence of objective abnormalities of coronary artery function.
Clinical utility
To assess the impact of disclosure of coronary function test results on clinical management (including treatment medication, investigations and healthcare resource utilisation).
Cardiovascular biomarkers
Hypothesis: Compared with standard care, stratified medicine improves circulating biomarkers of cardiovascular risk
Sex differences
To assess for similarities and differences in presenting characteristics, socio-economic status, treatment, health status and clinical outcomes between males and females.
Ischaemic heart disease
To assess for similarities and differences in presenting characteristics, socio-economic status, treatment, health status and clinical outcomes between patient with obstructive coronary artery disease and no obstructive CAD (including by endotype).
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NHS Greater Glasgow and Clyde
Lead sponsor
University of Glasgow
Collaborator
Abbott Medical Devices
Collaborator
