Oxygen therapy for heart attack recovery
Supersaturated Oxygen Therapy Using Radial Artery Access to Prevent Left Ventricular Remodeling After Anterior ST-segment Elevation Myocardial Infarction: a Randomized, Controlled Trial
This study is testing if giving extra oxygen to heart attack patients right after their treatment can help them recover better and avoid heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NHS National Waiting Times Centre Board Academic / other |
| Locations | 1 site (Clydebank, Dunbartonshire) |
| Trial ID | NCT06662890 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of supersaturated oxygen therapy on patients who have experienced an acute anterior ST-segment elevation myocardial infarction (STEMI) and have undergone primary percutaneous coronary intervention (PCI). Patients presenting within 6 hours of symptom onset will be enrolled and randomized to receive either the oxygen therapy or a sham treatment after their PCI procedure. The study will assess various outcomes, including blood samples, imaging scans, and health questionnaires, to evaluate the therapy's effectiveness in preventing heart failure and improving heart function. The trial aims to provide new insights into treatment options for heart attack recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a STEMI within 6 hours and have undergone successful primary PCI.
Not a fit: Patients with severe heart valve issues, cardiogenic shock, or other significant complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the risk of heart failure and improve recovery outcomes for heart attack patients.
How similar studies have performed: While there have been few studies exploring oxygen therapy in this context, the approach is considered novel and has not been extensively tested in recent years.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Ischemic time ≤6 hours from symptom onset 3. Acute anterior ST-segment elevation myocardial infarction 4. Infarct-related left anterior descending coronary artery TIMI flow grade 2-3 at the end of PCI 5. Radial artery access 6. Partial pressure of oxygen (PaO2) \>80 mmHg (10.7 kPa) Exclusion Criteria: 1. Proximal coronary artery stenosis that restricts blood flow with the SSO2 catheter in place 2. Post-PCI non-stented dissection or perforation. 3. Moderate - severe heart valve stenosis, insufficiency, pericardial disease, or non-ischaemic cardiomyopathy 4. Known pregnancy. 5. Cardiogenic shock 6. Contra-indication to anticoagulation 7. Acute mechanical complication e.g., ventricular septal rupture, pseudoaneurysm, mitral regurgitation 8. Hemoglobin \<10 g/dL 9. Major bleeding or major surgery within the past two months 10. Contra-indication to cardiovascular magnetic resonance (CMR) imaging e.g., severe claustrophobia, metallic foreign body. 11. Lack of witness verbal consent.
Where this trial is running
Clydebank, Dunbartonshire
- Golden Jubilee National Hospital — Clydebank, Dunbartonshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Colin Berry, BSc MBChB PhD
- Email: colin.berry@glasgow.ac.uk
- Phone: 441419515180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.