iCorMicA - Stratified Medicine in Angina
iCorMicA
International Study of Coronary Microvascular Angina (iCorMicA): a Randomised, Controlled, Multicentre Trial and Registry
1 other identifier
interventional
1,500
4 countries
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 9, 2026
April 1, 2026
5.5 years
June 24, 2020
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (8)
Feasibility of stratified medicine
0-60 months
Safety of the interventional diagnostic procedure (IDP)
0-60 months
Diagnostic utility of the interventional diagnostic procedure (IDP)
0-60 months
Clinical utility
0-60 months
Health status
0-60 months
- +3 more secondary outcomes
Other Outcomes (3)
Cardiovascular biomarkers
0 months - 10 years
Sex differences
0 months - 10 years
Ischaemic heart disease
0 months - 10 years
Study Arms (2)
Intervention Group - Stratified Medicine
ACTIVE COMPARATORAll 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.
Standard Care Group
SHAM COMPARATORAll 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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
- Abbott Medical Devicescollaborator
Study Sites (39)
Mater Private Hsopital
Cork, Ireland
Mater Private Hospital
Dublin, Ireland
Radboud University Medical Centre
Nijmegen, Netherlands
5th Military Hospital
Krakow, Poland
Golden Jubilee National Hospital
Clydebank, Scotland, G814DY, United Kingdom
Aberdeen Royal Hospital
Aberdeen, United Kingdom
William Harvey Hospital
Ashford, United Kingdom
Basildon University Hospital - Essex Cardiothoracic Centre
Basildon, United Kingdom
Bedford Hospital NHS Trust
Bedford, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Blackburn Teaching Hospital
Blackburn, United Kingdom
Victoria Hospital
Blackpool, United Kingdom
Glan Clwyd Hospital
Bodelwyddan, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
St Peter's Hospital NHS Foundation Trust
Chertsey, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
University Hospital Hairmyres
East Kilbride, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Royal Free Hospital
London, NW3, United Kingdom
Barts Health NHS Trust - St. Bartholomew's Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Northwick Park Hospital
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Nottingham University Hospitals NHS TRUST
Nottingham, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Pinderfields General Hospital
Wakefield, United Kingdom
Watford general Hospital
Watford, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Related Publications (10)
Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas AHEM, Prescott E, Karam N, Appelman Y, Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group. Eur Heart J. 2020 Oct 1;41(37):3504-3520. doi: 10.1093/eurheartj/ehaa503.
PMID: 32626906BACKGROUNDBairey Merz CN, Pepine CJ, Walsh MN, Fleg JL. Ischemia and No Obstructive Coronary Artery Disease (INOCA): Developing Evidence-Based Therapies and Research Agenda for the Next Decade. Circulation. 2017 Mar 14;135(11):1075-1092. doi: 10.1161/CIRCULATIONAHA.116.024534.
PMID: 28289007BACKGROUNDFord TJ, Stanley B, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, Sidik N, McCartney P, Corcoran D, Collison D, Rush C, McConnachie A, Touyz RM, Oldroyd KG, Berry C. Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina: The CorMicA Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2841-2855. doi: 10.1016/j.jacc.2018.09.006. Epub 2018 Sep 25.
PMID: 30266608BACKGROUNDJespersen L, Hvelplund A, Abildstrom SZ, Pedersen F, Galatius S, Madsen JK, Jorgensen E, Kelbaek H, Prescott E. Stable angina pectoris with no obstructive coronary artery disease is associated with increased risks of major adverse cardiovascular events. Eur Heart J. 2012 Mar;33(6):734-44. doi: 10.1093/eurheartj/ehr331. Epub 2011 Sep 11.
PMID: 21911339BACKGROUNDSara JD, Widmer RJ, Matsuzawa Y, Lennon RJ, Lerman LO, Lerman A. Prevalence of Coronary Microvascular Dysfunction Among Patients With Chest Pain and Nonobstructive Coronary Artery Disease. JACC Cardiovasc Interv. 2015 Sep;8(11):1445-1453. doi: 10.1016/j.jcin.2015.06.017.
PMID: 26404197BACKGROUNDFord TJ, Yii E, Sidik N, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, McCartney P, Corcoran D, Collison D, Rush C, Stanley B, McConnachie A, Sattar N, Touyz RM, Oldroyd KG, Berry C. Ischemia and No Obstructive Coronary Artery Disease: Prevalence and Correlates of Coronary Vasomotion Disorders. Circ Cardiovasc Interv. 2019 Dec;12(12):e008126. doi: 10.1161/CIRCINTERVENTIONS.119.008126. Epub 2019 Dec 13.
PMID: 31833416BACKGROUNDFord TJ, Stanley B, Sidik N, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, McCartney P, Corcoran D, Collison D, Rush C, Sattar N, McConnachie A, Touyz RM, Oldroyd KG, Berry C. 1-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA). JACC Cardiovasc Interv. 2020 Jan 13;13(1):33-45. doi: 10.1016/j.jcin.2019.11.001. Epub 2019 Nov 11.
PMID: 31709984BACKGROUNDKnuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242. doi: 10.1093/eurheartj/ehz825.
PMID: 31504439BACKGROUNDOng P, Camici PG, Beltrame JF, Crea F, Shimokawa H, Sechtem U, Kaski JC, Bairey Merz CN; Coronary Vasomotion Disorders International Study Group (COVADIS). International standardization of diagnostic criteria for microvascular angina. Int J Cardiol. 2018 Jan 1;250:16-20. doi: 10.1016/j.ijcard.2017.08.068. Epub 2017 Sep 8.
PMID: 29031990BACKGROUNDAng DTY, Collison DG, McGeoch RJ, Carrick D, Sykes RA, Bradley C, Kamdar AL, Jong A, Brogan RA, MacDougall DA, McCartney PJ, Rocchiccioli JP, Apps AP, Murphy CA, Robertson KE, Shaukat A, Ghattas A, Joshi FR, Sood A, Good RIS, O'Rourke B, Eteiba H, Lindsay MM, McConnachie A, Berry C. Novel Contrast-Derived Indices of Coronary Microvascular Function: Potential Clinical and Cost Benefits. Circ Cardiovasc Interv. 2025 Jun;18(6):e015058. doi: 10.1161/CIRCINTERVENTIONS.124.015058. Epub 2025 May 1.
PMID: 40308206DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Colin Berry, MBChB, PhD
University of Glasgow
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Patients and clinicians responsible for downstream (post-catheter laboratory) care are blinded to the randomisation allocation group (i.e. are blinded to whether the patient was in the intervention or blinded/control group).
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2020
First Posted
December 19, 2020
Study Start
December 30, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2030
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After the study has completed
- Access Criteria
- Bone fide collaboration request