Actively Recruiting
Supersaturated Oxygen Therapy Using Radial Artery Access to Prevent Left Ventricular Remodeling After Anterior ST-segment Elevation Myocardial Infarction a Randomized, Controlled Trial
Led by NHS National Waiting Times Centre Board · Updated on 2025-02-24
56
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
N
NHS National Waiting Times Centre Board
Lead Sponsor
B
British Heart Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new approach to treat patients who have had a heart attack, specifically acute anterior ST-segment elevation myocardial infarction STEMI. This condition can cause serious damage to the heart muscle, leading to heart failure and early death. Despite many studies, few new treatments have shown success in preventing heart failure after a heart attack. This trial aims to explore the safety, feasibility, and possible benefits of increasing blood oxygen levels after the usual treatment. The standard treatment involves reopening the blocked heart artery through a procedure called primary percutaneous coronary intervention PCI using access via the wrist. After this, patients are randomly assigned to receive either supersaturated oxygen therapy or a sham procedure for one hour. Supersaturated oxygen therapy uses extra oxygenated blood infused back into the treated artery through the wrist, while the sham group undergoes a similar procedure without the oxygen infusion. Both groups will be monitored under blinded conditions to ensure unbiased results. Participants will undergo various assessments including blood tests, coronary angiography, heart MRI scans at 2-5 days and again at 3 months, and health questionnaires. Coronary microvascular function will be measured before and after the treatment or sham procedure. Follow-up visits will continue for up to one year, with health records monitored longer term. The main outcome measured is a heart-related blood marker at 3 months, along with secondary outcomes including heart function, infarct size, quality of life, and safety events.
CONDITIONS
Brief Title
Heart Attack Blood Oxygen Therapy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ischemic time 6 hours or less from symptom onset
- Acute anterior ST-segment elevation myocardial infarction
- Infarct-related left anterior descending coronary artery TIMI flow grade 2-3 at the end of PCI
- Radial artery access
- Partial pressure of oxygen (PaO2) greater than 80 mmHg (10.7 kPa)
You will not qualify if you...
- Proximal coronary artery stenosis that restricts blood flow with the SSO2 catheter in place
- Post-PCI non-stented dissection or perforation
- Moderate to severe heart valve stenosis, insufficiency, pericardial disease, or non-ischaemic cardiomyopathy
- Known pregnancy
- Cardiogenic shock
- Contra-indication to anticoagulation
- Acute mechanical complication such as ventricular septal rupture, pseudoaneurysm, or mitral regurgitation
- Hemoglobin less than 10 g/dL
- Major bleeding or major surgery within the past two months
- Contra-indication to cardiovascular magnetic resonance (CMR) imaging such as severe claustrophobia or metallic foreign body
- Lack of witnessed verbal consent
Research Team
C
Colin Berry, BSc MBChB PhD
K
Katherine Henry, PhD
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