Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

Summary

Patients with heart attack or heart injury are tested (angiogram) for blockages in their arteries. Patients may develop heart problems caused by damage to small (microvascular) blood vessels. Eplerenone, a mineralocorticoid receptor-selective antagonist, reduces blood vessel injury and is used to treat high blood pressure and heart failure. Aim: to test the use of eplerenone in patients with heart attack/heart injury an no obstructive coronary arteries and small vessel problems (coronary microvascular dysfunction). Patients admitted to hospitals in the West of Scotland (2.5 million) and referred for invasive management to the Golden Jubilee and Hairmyres hospitals because of a suspected heart attack heart will be invited to participate into a registry-based clinical trial. Screening, enrolment and verbal, informed consent will be obtained during the angiogram then written consent on the ward. Small vessel disease will be assessed using a 'diagnostic' guidewire during the standard angiogram. People with small vessel problems will be invited to participate in a clinical trial of usual care or eplerenone. Coronary microvascular dysfunction is defined as an index of microvascular resistance ≥25. Coronary flow reserve (CFR abnormal \<2.0), microvascular resistance reserve ratio (MRR, abnormal \<2.5), and resistance reserve ratio (RRR abnormal \<2.0), measured simultaneously with IMR, are predefined parameters of interest. Patients will be allocated into one of the 3 groups: * Group 1: Patients without coronary microvascular dysfunction. No eplerenone * Group 2: Patient with coronary microvascular dysfunction. Usual care, no eplerenone. * Group 3: Small vessels abnormal. Eplerenone tablets. The primary outcome for the trial will be reduced heart injury (biomarkers) in patients with microvascular disease. We will also test heart function (MRI scan) at enrolment and at six months. All patients (Groups 1, 2 and 3) will have an angiogram. Standard blood tests will be collected during the hospital stay, and then again at 1 and 6 months. Other outcomes include questionnaires (health status). We will gather information on longer-term health outcomes (hospitalisation, death) using confidential electronic record linkage. We will ask for permission to store blood samples for future research. The research will improve scientific knowledge about eplerenone therapy in this patient group. The study will create a repository of clinical samples and images which will provide vital data for studies of endotypes of myocardial infarction or injury with no obstructive coronary arteries.

Timeline

Start

2022-02-04

Primary completion

2026-07-31

Completion

2026-07-31

Publications

• Background Morrone D, Stefanini G, De Carlo M, Giannini C, Toth G, Prunea D, Zivelonghi C, Benedetti A, De Bruyne B, Wilgenhof A, Kanovsky J, Kala P, Holmvang L, Hasbak M, Hildick-Smith D, Cockburn J, Amabile N, Veugeois A, Hovasse T, Neylon A, Honton B, Farah B, Gori T, Knorr M, Wolf A, Schmit T, Hausleiter J, K KS, Abdel-Waha M, Feistritzer HJ, Woitek F, Linke A, Leick J, Afzal S, Alexopoulos D, Varlamos C, Tsioufis K, Dimitriadis K, Testa L, Squillace M, Conrotto F, D'Ascenzo F, Campo G, Cocco M, Di Mario C, Caniato F, Ribichini FL, Prati D, Tarantini G, Cardaioli F, Burzotta F, Paraggio L, Bedogni F, Arzuffi L, Chieffo A, Ghizzoni G, Davidavicius G, Budrys P, Van Mieghem N, Daemen J, Brinkmann R, Bante H, Lesiak M, Iwanczyk S, Pregowski J, Skowronski J, Madeira S, Raposo L, Estevez-Loureiro R, Sisinni A, Escaned J, Jeronimo A, Moreno R, Jimenez-Valero S, Vriesendorp P, Pustjens T, Van Geuns R, Damman P, Van de Hoef T, Van der Harst P, Mamas MA, Duckett S, Mikhail G, Lucarelli C, Berry C, De Caterina R. Myocardial infarction with nonobstructive coronary arteries - the European PERspective (SNIPER) survey. J Cardiovasc Med (Hagerstown). 2025 Dec 1;26(12):731-740. doi: 10.2459/JCM.0000000000001808. Epub 2025 Dec 5.
• Background Berry C, Sykes RA, Tan D. MINOCA: a call for randomized trials. Eur Heart J. 2026 Mar 24;47(12):1467-1469. doi: 10.1093/eurheartj/ehaf1075. No abstract available.
• Background Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
• Background Sykes R, Doherty D, Mangion K, Morrow A, Berry C. What an Interventionalist Needs to Know About MI with Non-obstructive Coronary Arteries. Interv Cardiol. 2021 Jun 10;16:e10. doi: 10.15420/icr.2021.10. eCollection 2021 Apr.
• Background Pelliccia F, Pepine CJ, Berry C, Camici PG. The role of a comprehensive two-step diagnostic evaluation to unravel the pathophysiology of MINOCA: A review. Int J Cardiol. 2021 Aug 1;336:1-7. doi: 10.1016/j.ijcard.2021.05.045. Epub 2021 Jun 1.
• Background Ford TJ, Ong P, Sechtem U, Beltrame J, Camici PG, Crea F, Kaski JC, Bairey Merz CN, Pepine CJ, Shimokawa H, Berry C; COVADIS Study Group. Assessment of Vascular Dysfunction in Patients Without Obstructive Coronary Artery Disease: Why, How, and When. JACC Cardiovasc Interv. 2020 Aug 24;13(16):1847-1864. doi: 10.1016/j.jcin.2020.05.052.
• Background Bairey Merz CN, Pepine CJ, Shimokawa H, Berry C. Treatment of coronary microvascular dysfunction. Cardiovasc Res. 2020 Mar 1;116(4):856-870. doi: 10.1093/cvr/cvaa006.
• Background Ford 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.

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