[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NHS National Waiting Times Centre Board\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100454534","phase-2-stratified-medicine-of-eplerenone-in-acute-myocardial-infarction-or-injury-and-no-obstructive-coronary-arteries-100454534",false,"NCT05198791","Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.","The Effect of Mineralocorticoid Receptor Antagonist Therapy in Patients With Acute Myocardial Infection or Injury and no Obstructive Coronary Arteries: a Registry-based, Stratified-medicine, Randomized, Controlled Trial","StratMedMINOCA","Inclusion Criteria:\n\n* Age ≥18 years.\n* Acute myocardial infarction or myocardial injury and no obstructive coronary arteries.\n* Cardiovascular risk factor (≥1): age \\>70 years, atrial fibrillation, diabetes, current smoker, eGFR 30 - 60 mL\u002F minute\u002F1.73 m2, prior MI, treated hypertension or COVID-19 (confirmed or suspected)\n* Coronary angiography.\n\nExclusion Criteria (trial):\n\n* Obstructive coronary artery disease\n* Left ventricular ejection fraction ≤40% with evidence of heart failure, following myocardial infarction.\n* Estimated glomerular filtration rate \\\u003C30 mL\u002F minute\u002F1.73 m2\n* Severe liver impairment\n* Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test and who are unwilling or unable to follow the reproductive restrictions defined in the eligibility criteria and use highly effective contraception as defined in Appendix 2 for the duration of the study treatment and 30 days after last dose of study drug.\n* Patients taking one of the following medicines :\n* Pre-existing treatment with an MRA :\n* Anti-fungal drugs (ketoconazole or itraconazole).\n* Antiviral medication (nelfinavir or ritonavir).\n* Antibiotics (clarithromycin or telithromycin).\n* Nefazodone used to treat depression.\n* The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together.\n\nExclusion Criteria (registry):\n\n* Contra-indication to cardiovascular magnetic resonance imaging e.g. severe claustrophobia, metallic foreign body.\n* Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree atrio-ventricular block and sick sinus syndrome.\n* Lack of informed consent.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.\n\nAim: to test the use of eplerenone in patients with heart attack\u002Fheart injury an no obstructive coronary arteries and small vessel problems (coronary microvascular dysfunction).\n\nPatients 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 \\\u003C2.0), microvascular resistance reserve ratio (MRR, abnormal \\\u003C2.5), and resistance reserve ratio (RRR abnormal \\\u003C2.0), measured simultaneously with IMR, are predefined parameters of interest.\n\nPatients will be allocated into one of the 3 groups:\n\n* Group 1: Patients without coronary microvascular dysfunction. No eplerenone\n* Group 2: Patient with coronary microvascular dysfunction. Usual care, no eplerenone.\n* Group 3: Small vessels abnormal. Eplerenone tablets.\n\nThe 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.\n\nThe 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.",[27,28,29],"Myocardial Infarction, Acute","Myocardial Infarction With Nonobstructive Coronary Arteries","Myocardial Injury",[31,32,33,34,35,36],"Stratified Medicine","Mineralocorticoid receptor antagonists","MINOCA","Myocardial injury","Myocardial infarction","Myocardial Infarction with Nonobstructive Coronary Arteries","RECRUITING","2026-03-12",{"date":40,"type":41},"2026-03-16","ACTUAL",{"date":43,"type":41},"2022-02-04",{"date":45,"type":21},"2026-07-31",{"name":47,"class":48},"NHS National Waiting Times Centre Board","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100567031","heart-attack-blood-oxygen-therapy-trial-100567031","NCT06662890","Heart Attack Blood Oxygen Therapy Trial","Supersaturated Oxygen Therapy Using Radial Artery Access to Prevent Left Ventricular Remodeling After Anterior ST-segment Elevation Myocardial Infarction: a Randomized, Controlled Trial","SSO2 Radial MI","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Ischemic time ≤6 hours from symptom onset\n3. Acute anterior ST-segment elevation myocardial infarction\n4. Infarct-related left anterior descending coronary artery TIMI flow grade 2-3 at the end of PCI\n5. Radial artery access\n6. Partial pressure of oxygen (PaO2) \\>80 mmHg (10.7 kPa)\n\nExclusion Criteria:\n\n1. Proximal coronary artery stenosis that restricts blood flow with the SSO2 catheter in place\n2. Post-PCI non-stented dissection or perforation.\n3. Moderate - severe heart valve stenosis, insufficiency, pericardial disease, or non-ischaemic cardiomyopathy\n4. Known pregnancy.\n5. Cardiogenic shock\n6. Contra-indication to anticoagulation\n7. Acute mechanical complication e.g., ventricular septal rupture, pseudoaneurysm, mitral regurgitation\n8. Hemoglobin \\\u003C10 g\u002FdL\n9. Major bleeding or major surgery within the past two months\n10. Contra-indication to cardiovascular magnetic resonance (CMR) imaging e.g., severe claustrophobia, metallic foreign body.\n11. Lack of witness verbal consent.",{"count":58,"type":21},56,[60],"NA","'Heart attack', known as acute ST-segment elevation myocardial infarction, is a leading cause of heart failure and death. A lack of blood and oxygen damages the heart muscle potentially causing heart failure and premature death.\n\nDuring the past 25 years, despite intensive research efforts, few, if any new medicines have been shown to prevent heart failure after a heart attack. New treatment approaches are needed.\n\nThe standard treatment for a heart attack is for a doctor to reopen the blocked blood vessel. The treatment is called primary percutaneous coronary intervention, or 'primary PCI'. The doctor places a thin plastic tube in a blood vessel in the wrist. The doctor then passes a longer thin tube via the wrist into the blocked heart artery. A small balloon is then used to open the blockage and a thin metal tube (stent) is placed inside the blood vessel to keep it open. The patient then returns to the ward.\n\nSupersaturated oxygen therapy is designed to increase the blood oxygen level after the stent has been placed. The treatment lasts for one hour. The treatment is approved (CE-mark, FDA-approved) for patients presenting to doctors within 6 hours of symptoms onset. Supersaturated oxygen therapy is supported by results from two prior studies (AMIHOT, AMIHOT-II). Previously, the approach involved passing the plastic tubes via the femoral artery in the groin, limiting adoption. Since using the wrist is now standard care approach for heart attack treatment, our idea is to give supersaturated oxygen therapy via the wrist rather than the groin.\n\nIn this research study, we aim to assess the feasibility, safety and potential benefits of increasing blood oxygen content in patients who have been treated for a heart attack. The novel aspects of the study including giving the therapy via the wrist, the dummy procedure (sham\u002Fplacebo), the randomized treatment assignment (coin-flip, play of chance), and the masking (blinding) of the patient participating in the study and the attending clinical staff, investigators and outcome assessors.\n\nPatients who have been successfully treated for a heart attack will be invited to give informed consent at the end of the procedure. Fifty-six patients who have experienced a heart attack affecting the main area of the heart (anterior wall) will receive supersaturated therapy, or a dummy procedure, for one hour. The dummy procedure involves local anesthetic in the wrist and a pressure band as would normally be done.\n\nThe study also involves measuring small vessel function before and after the supersaturated oxygen \u002F dummy procedure, a heart MRI scan at 2-5 days and again 3 months later, health questionnaires and blood samples to assess heart injury and to be stored for future research.\n\nThe study will provide information on safety, feasibility and preliminary insights into potential benefits to patients. The study will clarify whether a much larger study is warranted.",[63,64],"Myocardial Infarct","Remodeling, Left Ventricle",[66,67,68,69,70,71,72,73],"myocardial infarction","primary percutaneous coronary intervention","heart failure","adverse ventricular remodelling","biomarkers","coronary microvascular function","PREMS","PROMS","2025-02-21",{"date":76,"type":41},"2025-02-24",{"date":78,"type":41},"2024-10-25",{"date":80,"type":21},"2038-11-01",{"name":47,"class":48},1,""]