Type 2 myocardial infarction and myocardial injury: eligibility for novel medical therapy to de-risk clinical trials

Sykes, R. , Briscoe, M., Krystofiak, T., Peck, O., Mangion, K. and Berry, C. (2021) Type 2 myocardial infarction and myocardial injury: eligibility for novel medical therapy to de-risk clinical trials. Open Heart, 8, e001633. (doi: 10.1136/openhrt-2021-001633) (PMID:34083388) (PMCID:PMC8174491)

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Abstract

Background Patients with type 2 myocardial infarction (T2MI) and other mechanisms of nonthrombotic myocardial injury have an unmet therapeutic need. Eligibility for novel medical therapy is generally uncertain. Methods We predefined colchicine, eplerenone and ticagrelor as candidates for repurposing towards novel therapy for T2MI or myocardial injury. Considering eligibility for randomisation in a clinical trial, each drug was classified according to indications and contraindications for therapy and survival for at least 24 hours following admission. Eligibility criteria for prescription were evaluated against the Summary of Medical Product Characteristics. Consecutive hospital admissions were screened to identify patients with ≥1 high-sensitivity troponin-I value >99th percentile. Endotypes of myocardial injury were adjudicated according to the Fourth Universal Definition of MI. Patients’ characteristics and medication were prospectively evaluated. Results During 1 March to 15 April 2020, 390 patients had a troponin I>URL. Reasons for exclusion: type 1 MI n=115, indeterminate diagnosis n=42, lack of capacity n=14, death <24 hours n=7, duplicates n=2. Therefore, 210 patients with T2MI/myocardial injury and 174 (82.8%) who survived to discharge were adjudicated for treatment eligibility. Patients who fulfilled eligibility criteria initially on admission and then at discharge were colchicine 25/210 (11.9%) and 23/174 (13.2%); eplerenone 57/210 (27.1%) and 45/174 (25.9%); ticagrelor 122/210 (58.1%) and 98/174 (56.3%). Forty-six (21.9%) and 38 (21.8%) patients were potentially eligible for all three drugs on admission and discharge, respectively. Conclusion A reasonably high proportion of patients may be considered eligible for repurposing novel medical therapy in secondary prevention trials of type 2 MI/myocardial injury.

Item Type:Articles
Additional Information:Funding Professor Colin Berry is supported by research funding from the British Heart Foundation (PG/17/2532884; RE/13/5/30177; RE/18/6/34217) and Medical Research Council (UKRI/MRC MR/S018905/1).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Mangion, Dr Kenneth and Sykes, Dr Robert and Berry, Professor Colin
Authors: Sykes, R., Briscoe, M., Krystofiak, T., Peck, O., Mangion, K., and Berry, C.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Open Heart
Publisher:BMJ
ISSN:2053-3624
ISSN (Online):2053-3624
Published Online:02 June 2021
Copyright Holders:Copyright © Author(s) (or their employer(s)) 2021
First Published:First published in Open Heart 2021
Publisher Policy:Reproduced under a Creative Commons licence

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
301454CORonary MICrovascular Angina (CorMicA): a pilot trial with a nested MRI sub-studyColin BerryBritish Heart Foundation (BHF)PG/17/25/32884CAMS - Cardiovascular Science
190814BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177Institute of Cardiovascular & Medical Sciences
303944BHF Centre of ExcellenceRhian TouyzBritish Heart Foundation (BHF)RE/18/6/34217CAMS - Cardiovascular Science
303684A randomized, double-blind, placebo-controlled Phase 2A cross-over trial of oral zibotentan in patients with angina due to small vessel disease: a proof-of-concept, developmental trial for safety, efficacy and biomarkers developmentColin BerryMedical Research Council (MRC)MR/S018905/1CAMS - Cardiovascular Science