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

Status: Recruiting
Location: See all (2) 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
United Kingdom
Golden Jubilee National Hospital
RECRUITING
Clydebank
NHS Greater Glasgow and Clyde
NOT_YET_RECRUITING
Glasgow
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: 2030-12-30
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.
Sponsors
Collaborators: Abbott Medical Devices, University of Glasgow
Leads: NHS Greater Glasgow and Clyde

This content was sourced from clinicaltrials.gov