iCorMicA - Stratified Medicine in Angina
International Study of Coronary Microvascular Angina (iCorMicA): a Randomised, Controlled, Multicentre Trial and Registry
NHS Greater Glasgow and Clyde
1,500 participants
Dec 30, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
- Able to provide informed consent.
Exclusion Criteria4
- 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.
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Interventions
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.
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.
Locations(39)
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NCT04674449