iCorMicA - Stratified Medicine in Angina (iCorMicA)
Microvascular Angina, Angina, Stable, Ischemia With No Obstructive Coronary Arteries (INOCA)
About this trial
This is an interventional diagnostic trial for Microvascular Angina focused on measuring angina, microvascular angina, ischaemia with no obstructive coronary artery disease (INOCA), stratified medicine, clinical trial, outcomes research, prognosis, health economics
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Golden Jubilee National HospitalRecruiting
- NHS Greater Glasgow and Clyde
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Intervention Group - Stratified Medicine
Standard Care Group
All randomised participants will receive stratified medicine. The subjects will undergo functional coronary angiography involving guidewire-based coronary function tests (interventional diagnostic procedure, IDP) as an adjunct to invasive coronary angiography. The IDP results will be disclosed to the catheter laboratory clinician to clarify endotypes and re-evaluate the clinical diagnosis. Linked guideline-directed medical therapy and lifestyle measures will be recommended based on the endotype. The patient and clinicians responsible for downstream care will not be informed of the randomised group but they will be informed of the endotype and linked treatment plan, in the same way as in the Standard Care control group. They will be blinded to the allocated study arm and IDP findings.
All randomised participants in this arm will receive standard angiography-guided care. The endotype will be determined based on the angiogram and all of the available clinical information. The participants in this group will also receive the IDP at time of the angiogram. The results of the IDP will be concealed from the catheter laboratory clinician who will be blinded. The cardiac physiologist / clinical scientist will remain unblinded for the purpose of data recording and quality assurance. The sham procedure is intended to be the same as in the Intervention Group. Management of the patient is as per standard of care, with therapy linked to the diagnosis (endotype). The patient and clinicians responsible for downstream care will not be informed of the randomised group but they will be informed of the endotype and linked treatment plan in the same way as in the Intervention Group. They will be blinded to the allocated study arm and IDP findings.