Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial
Background: Novel strategies to limit the size of infarction and prevent adverse remodeling and heart failure in patients following acute ST-segment elevation myocardial infarction (STEMI) are lacking. Supersaturated oxygen (SSO2) therapy is approved for patients presenting within 6 h of onset of an...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-07-01
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| Series: | American Heart Journal Plus |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S266660222500059X |
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| author | Francis R. Joshi Maria Petty Yen Wing Ng Hamish Elliott Ross Anderson Douglas Gordon Rebecca Hanna Robert Sykes Shaun Leonard Andrew Morrow Dylan Tan Anna Kamdar Ramu Perumal Jeffrey L. Creech Peter Kellman Paul Welsh Alex McConnachie Colin Berry |
| author_facet | Francis R. Joshi Maria Petty Yen Wing Ng Hamish Elliott Ross Anderson Douglas Gordon Rebecca Hanna Robert Sykes Shaun Leonard Andrew Morrow Dylan Tan Anna Kamdar Ramu Perumal Jeffrey L. Creech Peter Kellman Paul Welsh Alex McConnachie Colin Berry |
| author_sort | Francis R. Joshi |
| collection | DOAJ |
| description | Background: Novel strategies to limit the size of infarction and prevent adverse remodeling and heart failure in patients following acute ST-segment elevation myocardial infarction (STEMI) are lacking. Supersaturated oxygen (SSO2) therapy is approved for patients presenting within 6 h of onset of anterior STEMI using femoral artery access. The feasibility of SSO2 therapy via radial access is unknown. A more detailed understanding of the effect of therapy is needed. Objectives: To assess the primary outcome, defined as the within-participant change in the plasma concentration of NT-proBNP measured at baseline, 24 h, 2–5 days and 3-months post-MI. Design: Prospective, randomized, controlled, blinded, endpoint (mechanistic, PROBE) clinical trial. Randomized, controlled trial: After primary PCI, eligible participants will be blinded and randomized 2:1 to either 1 h of SSO2 therapy using radial artery access and intravenous glycoprotein IIbIIIa inhibitor therapy or a control (sham) procedure involving wrist manipulation in addition to standard care. The primary outcome is the within-participant change in the plasma concentration of NT-proBNP as detailed above. Secondary outcome assessments include coronary microcirculatory function, infarct size, microvascular obstruction, myocardial hemorrhage, left ventricular remodeling, myocardial blood flow, quality of life (EQ-5D-5L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Duke Activity Status Index. Patient reported experience measures (PREMS) are an exploratory outcome. Health and economic outcomes will be assessed using electronic healthcare records. Value: The study will test the feasibility of radial artery access, provide mechanistic data and inform a larger multicenter trial powered to detect treatment effects on clinical endpoints.Clinicaltrials.gov: NCT06662890 |
| format | Article |
| id | doaj-art-d8f744386ef64902bca894564ba907da |
| institution | OA Journals |
| issn | 2666-6022 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | American Heart Journal Plus |
| spelling | doaj-art-d8f744386ef64902bca894564ba907da2025-08-20T02:05:13ZengElsevierAmerican Heart Journal Plus2666-60222025-07-015510055610.1016/j.ahjo.2025.100556Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trialFrancis R. Joshi0Maria Petty1Yen Wing Ng2Hamish Elliott3Ross Anderson4Douglas Gordon5Rebecca Hanna6Robert Sykes7Shaun Leonard8Andrew Morrow9Dylan Tan10Anna Kamdar11Ramu Perumal12Jeffrey L. Creech13Peter Kellman14Paul Welsh15Alex McConnachie16Colin Berry17NHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United KingdomZOLL Medical Corporation, Chelmsford, MA, United StatesZOLL Medical Corporation, Chelmsford, MA, United StatesNational Heart Lung and Blood Institute, Bethesda, MD, United StatesBritish Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United KingdomRobertson Centre for Biostatistics, University of Glasgow, Glasgow, United KingdomNHS Golden Jubilee National Hospital, Clydebank, United Kingdom; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; Corresponding author at: British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Medical Health, 126 University Place, University of Glasgow, Glasgow, G12 8TA, Scotland, United Kingdom.Background: Novel strategies to limit the size of infarction and prevent adverse remodeling and heart failure in patients following acute ST-segment elevation myocardial infarction (STEMI) are lacking. Supersaturated oxygen (SSO2) therapy is approved for patients presenting within 6 h of onset of anterior STEMI using femoral artery access. The feasibility of SSO2 therapy via radial access is unknown. A more detailed understanding of the effect of therapy is needed. Objectives: To assess the primary outcome, defined as the within-participant change in the plasma concentration of NT-proBNP measured at baseline, 24 h, 2–5 days and 3-months post-MI. Design: Prospective, randomized, controlled, blinded, endpoint (mechanistic, PROBE) clinical trial. Randomized, controlled trial: After primary PCI, eligible participants will be blinded and randomized 2:1 to either 1 h of SSO2 therapy using radial artery access and intravenous glycoprotein IIbIIIa inhibitor therapy or a control (sham) procedure involving wrist manipulation in addition to standard care. The primary outcome is the within-participant change in the plasma concentration of NT-proBNP as detailed above. Secondary outcome assessments include coronary microcirculatory function, infarct size, microvascular obstruction, myocardial hemorrhage, left ventricular remodeling, myocardial blood flow, quality of life (EQ-5D-5L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Duke Activity Status Index. Patient reported experience measures (PREMS) are an exploratory outcome. Health and economic outcomes will be assessed using electronic healthcare records. Value: The study will test the feasibility of radial artery access, provide mechanistic data and inform a larger multicenter trial powered to detect treatment effects on clinical endpoints.Clinicaltrials.gov: NCT06662890http://www.sciencedirect.com/science/article/pii/S266660222500059XSupersaturated oxygenSTEMITransradialHeart failure |
| spellingShingle | Francis R. Joshi Maria Petty Yen Wing Ng Hamish Elliott Ross Anderson Douglas Gordon Rebecca Hanna Robert Sykes Shaun Leonard Andrew Morrow Dylan Tan Anna Kamdar Ramu Perumal Jeffrey L. Creech Peter Kellman Paul Welsh Alex McConnachie Colin Berry Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial American Heart Journal Plus Supersaturated oxygen STEMI Transradial Heart failure |
| title | Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial |
| title_full | Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial |
| title_fullStr | Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial |
| title_full_unstemmed | Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial |
| title_short | Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial |
| title_sort | supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior st segment elevation myocardial infarction a randomized controlled trial |
| topic | Supersaturated oxygen STEMI Transradial Heart failure |
| url | http://www.sciencedirect.com/science/article/pii/S266660222500059X |
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