Heart attack blood oxygen therapy study.
Research type
Research Study
Full title
Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodelling after acute anterior ST-segment elevation myocardial infarction: a randomised, controlled trial.
IRAS ID
334915
Contact name
Colin Berry
Contact email
Sponsor organisation
Golden Jubilee National Hospital / National Waiting Times Board
Duration of Study in the UK
9 years, 11 months, 23 days
Research summary
'Heart attack', known as acute ST-segment elevation myocardial infarction (STEMI), is a leading global cause of heart failure and death. Initial damage to the heart muscle causes progressive enlargement, heart failure and, sadly, premature death.
During the past 25 years, despite intensive research, no new medicines or devices have been shown to reduce heart failure after STEMI. New approaches merit being assessed.
STEMI is caused by a sudden cessation in the supply of oxygenated blood to the heart muscle. Primary percutaneous coronary intervention (primary PCI) is the evidence-based standard of care to reopen the blocked heart artery. PCI invovles using a radial artery in the wrist to pass a catheter (thin tube) into the blocked heart artery, open it with a balloon and then place a stent to keep the artery open. The patient then returns to the ward.
We propose a pilot study of a treatment that increases the oxygen content of blood. 'Supersaturated oxygen (SSO2)' therapy is CE-marked to treat patients with anterior STEMI within 6 hours of symptom onset. Previously, the approach involved femoral artery access, however, since radial artery access is standard care, SSO2 therapy is not used. Furthermore, SSO2 therapy has limited clinical evidence (AMIHOT, AMIHOT-II studies). We hypothesise that SSO2 therapy via radial access following primary PCI will be feasible, safe, and beneficial. In this pilot trial, following informed consent at the end of primary PCI, 56 patients with anterior STEMI will be randomised 2:1 to standard care with or without SSO2 therapy over 1 hour. The protocol involves measuring cardiacl small vessel function, a heart MRI scan 2-5 days and 3 months later, questionnaires and blood samples to assess heart attack injury and to be stored for future research. The pilot will inform the rationale for a larger trial designed to assess heart failure.
REC name
West of Scotland REC 5
REC reference
24/WS/0006
Date of REC Opinion
29 Jan 2024
REC opinion
Further Information Favourable Opinion