RECRUITINGINTERVENTIONAL

iCorMicA - Stratified Medicine in Angina

International Study of Coronary Microvascular Angina (iCorMicA): a Randomised, Controlled, Multicentre Trial and Registry

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years. 2. A clinical plan for invasive coronary angiography. 3. Symptoms of angina (typical or atypical) according to the Rose- and/or Seattle Angina questionnaires. 4. Able to comply with study procedures. 5. Able to provide willing to sign a consent form. Who Should NOT Join This Trial: 1. A non-coronary primary indication for invasive angiography (e.g. valve disease, heart failure). 2. History of coronary artery bypass surgery. 3. 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\*. 4. Logistical reason\*. \*These patients will enter a follow-up registry. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age ≥18 years. 2. A clinical plan for invasive coronary angiography. 3. Symptoms of angina (typical or atypical) according to the Rose- and/or Seattle Angina questionnaires. 4. Able to comply with study procedures. 5. Able to provide informed consent. Exclusion Criteria: 1. A non-coronary primary indication for invasive angiography (e.g. valve disease, heart failure). 2. History of coronary artery bypass surgery. 3. 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\*. 4. Logistical reason\*. \*These patients will enter a follow-up registry.

Treatments Being Tested

DIAGNOSTIC_TEST

Disclosure of IDP results

The 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.

OTHER

IDP performed but results not disclosed

The 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.