Effect of Supersaturated Oxygen Therapy on Coronary Microcirculatory Function in Patients With Anterior STEMI.
Doosup Shin, Neng Dai, Paul Wilburn...
https://pubmed.ncbi.nlm.nih.gov/37676228/Actively Recruiting
Led by NHS National Waiting Times Centre Board · Updated on 2025-02-24
56
Participants Needed
1
Research Sites
521 weeks
Total Duration
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
Heart Attack Blood Oxygen Therapy Trial
C
Colin Berry, BSc MBChB PhD
K
Katherine Henry, PhD
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NHS National Waiting Times Centre Board
Lead Sponsor
British Heart Foundation
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility confirmation before PCI
Duration - Approximately 1 hour for the intervention or control procedure
Participants undergo primary percutaneous coronary intervention (PCI) followed immediately by either supersaturated oxygen therapy using radial artery access or a sham control procedure in the cardiac catheter laboratory.
1 in-person visit during PCI and treatment in the catheter laboratory
Duration - Up to 12 months
Participants are followed up with in-person visits and electronic health record assessments to monitor heart function, quality of life, and safety for up to 12 months after treatment.
Multiple in-person visits up to 12 months and ongoing electronic health record follow-up
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/27803036/NHS National Waiting Times Centre Board
Lead Sponsor
British Heart Foundation
Collaborating Sponsor