Heart Attack Blood Oxygen Therapy Trial

NCT06662890 | Recruiting

• 1 other identifier: 23/CARD/34
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myocardial infarction; primary percutaneous coronary intervention; heart failure; adverse ventricular remodelling; biomarkers; coronary microvascular function; PREMS; PROMS

Outcome Measures

Primary Outcomes (1)

• N-terminal pro-B-type natriuretic peptide

  N-terminal pro-B-type natriuretic peptide plasma concentration, within-subject change post-enrolment during follow-up.

  3 months from baseline

Secondary Outcomes (10)

• Coronary microvascular function

  2 hours from baseline

• Infarct size

  2-5 days after enrolment

• Microvascular obstruction

  2-5 days after enrolment

• Myocardial hemorrhage

  2-5 days after enrolment

• Left ventricular remodeling

  3 months from baseline

Study Arms (2)

Supersaturated oxygen therapy using radial artery access

EXPERIMENTAL

Supersaturated O2 (SSO2) therapy immediately following primary percutaneous coronary intervention using radial artery access in the cardiac catheter laboratory.

Other: Supersaturated oxygen

Control group

SHAM COMPARATOR

Control (sham) procedure in addition to standard care

Other: Sham (No Treatment)

Interventions

Supersaturated oxygen OTHER

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

Supersaturated oxygen therapy using radial artery access

Sham (No Treatment) OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Ischemic time ≤6 hours 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) \>80 mmHg (10.7 kPa)

You may not qualify if:

• Proximal coronary artery stenosis that restricts blood flow with the SSO2 catheter in place
• Post-PCI non-stented dissection or perforation.
• Moderate - severe heart valve stenosis, insufficiency, pericardial disease, or non-ischaemic cardiomyopathy
• Known pregnancy.
• Cardiogenic shock
• Contra-indication to anticoagulation
• Acute mechanical complication e.g., ventricular septal rupture, pseudoaneurysm, mitral regurgitation
• Hemoglobin \<10 g/dL
• Major bleeding or major surgery within the past two months
• Contra-indication to cardiovascular magnetic resonance (CMR) imaging e.g., severe claustrophobia, metallic foreign body.
• Lack of witness verbal consent.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• British Heart Foundation: collaborator
• Zoll Medical Corporation: collaborator
• Robertson Centre for Biostatistics - University of Glasgow: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, Dunbartonshire, G81 4DY, United Kingdom

RECRUITING

Related Publications (7)

• Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.

  PMID: 20031745 BACKGROUND

• Falah B, Kotinkaduwa LN, Schonning MJ, Redfors B, de Waha S, Granger CB, Maehara A, Eitel I, Thiele H, Stone GW. Microvascular Obstruction in Patients With Anterior STEMI Treated With Supersaturated Oxygen. J Soc Cardiovasc Angiogr Interv. 2024 Apr 6;3(5):101356. doi: 10.1016/j.jscai.2024.101356. eCollection 2024 May.

  PMID: 39132455 BACKGROUND

• Chen S, David SW, Khan ZA, Metzger DC, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. One-year outcomes of supersaturated oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2021 May 1;97(6):1120-1126. doi: 10.1002/ccd.29090. Epub 2020 Jul 10.

  PMID: 32649037 BACKGROUND

• Shin D, Dai N, Wilburn P, Choi KH, Lee SH, Kim HK, Maehara A, Stone GW, Myung Lee J. Effect of Supersaturated Oxygen Therapy on Coronary Microcirculatory Function in Patients With Anterior STEMI. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2469-2471. doi: 10.1016/j.jcin.2023.08.001. Epub 2023 Sep 6. No abstract available.

  PMID: 37676228 BACKGROUND

• Carrick D, Haig C, Ahmed N, Carberry J, Yue May VT, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Mahrous A, Mordi I, Ford I, Radjenovic A, Oldroyd KG, Berry C. Comparative Prognostic Utility of Indexes of Microvascular Function Alone or in Combination in Patients With an Acute ST-Segment-Elevation Myocardial Infarction. Circulation. 2016 Dec 6;134(23):1833-1847. doi: 10.1161/CIRCULATIONAHA.116.022603. Epub 2016 Nov 1.

  PMID: 27803036 BACKGROUND

• Carrick D, Haig C, Ahmed N, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay MM, Davie A, Mahrous A, Mordi I, Rauhalammi S, Sattar N, Welsh P, Radjenovic A, Ford I, Oldroyd KG, Berry C. Myocardial Hemorrhage After Acute Reperfused ST-Segment-Elevation Myocardial Infarction: Relation to Microvascular Obstruction and Prognostic Significance. Circ Cardiovasc Imaging. 2016 Jan;9(1):e004148. doi: 10.1161/CIRCIMAGING.115.004148.

  PMID: 26763281 BACKGROUND

• Joshi FR, Petty M, Ng YW, Elliott H, Anderson R, Gordon D, Hanna R, Sykes R, Leonard S, Morrow A, Tan D, Kamdar A, Perumal R, Creech JL, Kellman P, Welsh P, McConnachie A, Berry C. Supersaturated oxygen therapy using radial artery access to prevent left ventricular remodeling after anterior ST-segment elevation myocardial infarction: a randomized, controlled trial. Am Heart J Plus. 2025 May 28;55:100556. doi: 10.1016/j.ahjo.2025.100556. eCollection 2025 Jul.

  PMID: 40510547 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Ventricular Remodeling; Heart Failure

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Central Study Contacts

Colin Berry, BSc MBChB PhD

CONTACT

441419515180; colin.berry@glasgow.ac.uk

Katherine Henry, PhD

CONTACT

katherine.henry@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology and Imaging

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2038
• Last Updated: February 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: To be confirmed
• Access Criteria: Bone fide researchers, subject to sponsor approval

Locations

GB (1)