International Study of Coronary Microvascular Angina (iCorMicA): a Randomised, Controlled, Multicentre Trial and Registry
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Ireland
Mater Private Hsopital
COMPLETED
Cork
Mater Private Hospital
COMPLETED
Dublin
Netherlands
Radboud University Medical Centre
RECRUITING
Nijmegen
Poland
5th Military Hospital
RECRUITING
Krakow
United Kingdom
Aberdeen Royal Hospital
COMPLETED
Aberdeen
William Harvey Hospital
RECRUITING
Ashford
Basildon University Hospital - Essex Cardiothoracic Centre
COMPLETED
Basildon
Bedford Hospital NHS Trust
RECRUITING
Bedford
Royal Victoria Hospital
RECRUITING
Belfast
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Royal Blackburn Teaching Hospital
RECRUITING
Blackburn
Victoria Hospital
RECRUITING
Blackpool
Glan Clwyd Hospital
RECRUITING
Bodelwyddan
Royal Bournemouth Hospital
COMPLETED
Bournemouth
Royal Papworth Hospital NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Cambridge
University Hospital of Wales
RECRUITING
Cardiff
St Peter's Hospital NHS Foundation Trust
RECRUITING
Chertsey
Golden Jubilee National Hospital
RECRUITING
Clydebank
University Hospitals Coventry & Warwickshire NHS Trust
RECRUITING
Coventry
University Hospital Hairmyres
RECRUITING
East Kilbride
NHS Greater Glasgow and Clyde
NOT_YET_RECRUITING
Glasgow
Raigmore Hospital
RECRUITING
Inverness
Leeds Teaching Hospital NHS Trust
RECRUITING
Leeds
Liverpool Heart and Chest Hospital
RECRUITING
Liverpool
Barts Health NHS Trust - St. Bartholomew's Hospital
ACTIVE_NOT_RECRUITING
London
King's College Hospital
RECRUITING
London
Northwick Park Hospital
RECRUITING
London
Royal Free Hospital
RECRUITING
London
The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Royal Gwent Hospital
RECRUITING
Newport
Nottingham University Hospitals NHS TRUST
RECRUITING
Nottingham
Queen Alexandra Hospital
RECRUITING
Portsmouth
Northern General Hospital
RECRUITING
Sheffield
University Hospital Southampton
RECRUITING
Southampton
South Tyneside and Sunderland NHS Foundation Trust
RECRUITING
Sunderland
Morriston Hospital
RECRUITING
Swansea
Pinderfields General Hospital
RECRUITING
Wakefield
Watford general Hospital
COMPLETED
Watford
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Colin Berry, MBChB, PhD
colin.berry@glasgow.ac.uk
+44 141 330 3325
Backup
Daniel Ang, MBChB
daniel.ang@glasgow.ac.uk
Time Frame
Start Date: 2020-12-30
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 1500
Treatments
Active_comparator: Intervention Group - Stratified Medicine
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.
Sham_comparator: Standard Care Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Abbott Medical Devices, University of Glasgow
Leads: NHS Greater Glasgow and Clyde