iCorMicA - Stratified medicine in angina

  • Research type

    Research Study

  • Full title

    International study of Coronary Microvascular Angina (iCorMicA): a randomised, controlled, multicentre trial and registry

  • IRAS ID

    280206

  • Contact name

    Colin Berry

  • Contact email

    colin.berry@glasgow.ac.uk

  • Sponsor organisation

    Greater Glasgow and Clyde, Research and Development Office

  • Clinicaltrials.gov Identifier

    NCT04674449

  • Duration of Study in the UK

    4 years, 11 months, 30 days

  • Research summary

    Coronary angiography is routinely performed for the investigation of angina. However, up to half of all patients undergoing elective coronary angiography for the investigation of angina have no obstructive disease (blockages) in their coronary arteries. We recently conducted the CorMicA pilot study in the Golden Jubilee National Hospital and Hairmyres Hospital. During a 12-month period, we enrolled 391 patients prior to having a coronary angiogram. 47% of these patients had no blockages. The patients had given consent for tests of coronary small vessel function to assess for whether microvascular and/or vasospastic angina might be common and if so, whether knowing the test results might lead to a change in the diagnosis, treatment and wellbeing of the patients. Allowing for logistics, 151 were then randomised by the cardiologists in the catheter laboratory to have the intervention group (stratified medicine/clinician using the additional results from the guide wire to determine treatment) or the control group (angiography-guided standard care/clinician not using the additional results from the guide wire to determine treatment). The results were encouraging overall. We now seek to determine in the iCorMicA trial whether the guidewire-based stratified medicine approach is feasible in different hospitals and countries in Europe and if so whether there are improvements in patients' wellbeing and healthcare resource utilisation. The primary outcome is the Seattle Angina Summary Score at 1 year. A registry will include patients with blocked coronary arteries (not eligible for randomisation) and the randomised patients. A blood sample will be collected for biomarkers and approvals requested for longer term follow-up, including be electronic record linkage.

  • REC name

    West of Scotland REC 5

  • REC reference

    20/WS/0098

  • Date of REC Opinion

    6 Aug 2020

  • REC opinion

    Further Information Favourable Opinion