Heart Attack Blood Oxygen Therapy Trial

Summary

'Heart attack', known as acute ST-segment elevation myocardial infarction, is a leading cause of heart failure and death. A lack of blood and oxygen damages the heart muscle potentially causing heart failure and premature death.

During the past 25 years, despite intensive research efforts, few, if any new medicines have been shown to prevent heart failure after a heart attack. New treatment approaches are needed.

The standard treatment for a heart attack is for a doctor to reopen the blocked blood vessel. The treatment is called primary percutaneous coronary intervention, or 'primary PCI'. The doctor places a thin plastic tube in a blood vessel in the wrist. The doctor then passes a longer thin tube via the wrist into the blocked heart artery. A small balloon is then used to open the blockage and a thin metal tube (stent) is placed inside the blood vessel to keep it open. The patient then returns to the ward.

Supersaturated oxygen therapy is designed to increase the blood oxygen level after the stent has been placed. The treatment lasts for one hour. The treatment is approved (CE-mark, FDA-approved) for patients presenting to doctors within 6 hours of symptoms onset. Supersaturated oxygen therapy is supported by results from two prior studies (AMIHOT, AMIHOT-II). Previously, the approach involved passing the plastic tubes via the femoral artery in the groin, limiting adoption. Since using the wrist is now standard care approach for heart attack treatment, our idea is to give supersaturated oxygen therapy via the wrist rather than the groin.

In this research study, we aim to assess the feasibility, safety and potential benefits of increasing blood oxygen content in patients who have been treated for a heart attack. The novel aspects of the study including giving the therapy via the wrist, the dummy procedure (sham/placebo), the randomized treatment assignment (coin-flip, play of chance), and the masking (blinding) of the patient participating in the study and the attending clinical staff, investigators and outcome assessors.

Patients who have been successfully treated for a heart attack will be invited to give informed consent at the end of the procedure. Fifty-six patients who have experienced a heart attack affecting the main area of the heart (anterior wall) will receive supersaturated therapy, or a dummy procedure, for one hour. The dummy procedure involves local anesthetic in the wrist and a pressure band as would normally be done.

The study also involves measuring small vessel function before and after the supersaturated oxygen / dummy procedure, a heart MRI scan at 2-5 days and again 3 months later, health questionnaires and blood samples to assess heart injury and to be stored for future research.

The study will provide information on safety, feasibility and preliminary insights into potential benefits to patients. The study will clarify whether a much larger study is warranted.

Conditions

• Myocardial Infarct
• Remodeling, Left Ventricle

Interventions

OTHER

Supersaturated oxygen

Supersaturated O2 (SSO2) therapy immediately following primary percutaneous coronary intervention (PCI) using radial artery access in the cardiac catheter laboratory. https://www.zoll.com/products/supersaturated-oxygen-therapy

OTHER

Sham (No Treatment)

Control (sham) procedure involving wrist manipulation in addition to standard care.

Sponsors & Collaborators

• British Heart Foundation

  collaborator OTHER

• Zoll Medical Corporation

  collaborator INDUSTRY

• Robertson Centre for Biostatistics - University of Glasgow

  collaborator UNKNOWN

• NHS National Waiting Times Centre Board

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-25

Primary Completion

2028-11-01

Completion

2038-11-01

Countries

• United Kingdom

Study Locations