Myocardial InfarctSSO2 Radial MINCT06662890
Heart Attack Blood Oxygen Therapy Trial
A study testing Supersaturated oxygen in people with Myocardial Infarct and Remodeling, Left Ventricle, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarct, Remodeling, Left Ventricle
- What is being tested?
- Supersaturated oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2024to 1 Nov 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katherine Henry, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Golden Jubilee National Hospital
Clydebank, Dunbartonshire, G81 4DY
Colin Berry, BSc MBChB PhD, 441419515180, colin.berry@glasgow.ac.uk
Francis Joshi, MBChB PhD
About this study
Official title: Supersaturated Oxygen Therapy Using Radial Artery Access to Prevent Left Ventricular Remodeling After Anterior ST-segment Elevation Myocardial Infarction: a Randomized, Controlled Trial
'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.
Read more
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.
Read the detailed description
This study is an academic, investigator-initiated clinical trial.
The design involves prospective enrolment of patients with a diagnosis of acute, anterior ST-segment elevation myocardial infarction (STEMI) presenting within 6 hours of symptom and undergoing primary PCI with radial artery acess. The protocol begins after standard, primary percutaneous coronary intervention (PCI). The timepoint for randomization (time zero) is at the end of successful primary PCI. Eligibility criteria include successful completion of primary PCI, defined as TIMI flow grade 2-3 in the left anterior descending coronary artery.
Given that the initial point of urgent/emergency care is in the catheter laboratory, the consent process will involve an initial witnessed verbal informed consent followed by randomization. This approach is in line with prior research in our hospital, contemporary evidence, feedback from experts with lived experience and international practice guidelines [PMID: 37622654 PMID: 32143733]. The Patient Information Sheet and Consent form will be provided to patients and carers on the ward after the angiogram. If the patient agrees to continue in the study then written informed consent will be obtained on the ward.
The study assessments will involve a blood sample, coronary angiography, coronary physiology, cardiovascular magnetic resonance (CMR) imaging scans, health status questionnaires, and electronic case record linkage. If the patient is eligible to participate and agrees to have electronic health record linkage follow-up but no other assessments or procedures, then consent will be invited for electronic health record follow-up only (no visits).
Informed consent will initially be obtained following arrival in the catheter laboratory. Blood samples would be obtained following arterial sheath insertion before PCI (since hemodilution due to the volume of radiographic contrast media may confound the analysis) study begins at the end of standard care primary PCI. Patients who fulfil the eligibility criteria and who have given written witnessed informed assent will be randomly assigned (2:1) to the intervention group or the control group.
Coronary microvascular function will be assessed in all patients at the end of the standard care primary PCI. The diagnostic guidewire should be positioned in the left anterior descending coronary artery using X-ray fluoroscopy. This will be repeated at the end of the intervention / control procedure.
Intervention group SSO2 therapy involves withdrawal of arterial blood, extra-corporeal hyper-oxygenation (ZOLL Circulation Inc console), and infusion of the hyper oxygenated blood into the PCI-treated left anterior descending coronary artery. The hyper oxygenated blood is returned using a standard catheter positioned in the left main coronary artery, via radial artery access. Therefore, temporary radial artery access using one or both radial arteries is needed for the one-hour duration of the SSO2 therapy in the cardiac catheter laboratory. Blinding measures will be implemented, including after returning to the coronary care unit until the end of the study.
Control group To minimize bias, patients assigned to the control group would follow the same schedule as if they were assigned to the intervention group. A control procedure will be undertaken. This procedure will mimic the actual procedure but without additional artery access i.e. no oxygen catheter therapy. The control procedure will involve conscious sedation, local anesthetic given in the usual way in the radial area, manual pressure, activation of the ZOLL Circulation Inc console (without the blood circuit), and then application of the radial closure device. The patient will be cared for by the clinical team in the usual way. The patient will remain blind to treatment group allocation, including after returning to the coronary care unit until the end of the study. Blinding to treatment group assignment will be prospectively documented.
Participants will be followed up with in person contacts up to 1-year post enrolment. Electronic health records may be checked without participant contact into the longer term.
- Conditions
- Myocardial Infarct, Remodeling, Left Ventricle
- Being tested
- Supersaturated oxygen, Sham (No Treatment)
- Keywords
- myocardial infarction, primary percutaneous coronary intervention, heart failure, adverse ventricular remodelling, biomarkers, coronary microvascular function, PREMS, PROMS
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supersaturated oxygenOther
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
Sham (No Treatment)Other
Control (sham) procedure involving wrist manipulation in addition to standard care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Supersaturated oxygen |
| Control group | Sham comparator | Control (sham) procedure in addition to standard care Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-terminal pro-B-type natriuretic peptide
N-terminal pro-B-type natriuretic peptide plasma concentration, within-subject change post-enrolment during follow-up.
Measured: 3 months from baseline
Secondary outcomes (10)
Coronary microvascular function
Coronary microvascular function measured by bolus thermodilution
Measured: 2 hours from baseline
Infarct size
Size of myocardial infarction (% left ventricular mass) measured by contrast-enhanced cardiovascular magnetic resonance (CMR) imaging
Measured: 2-5 days after enrolment
Microvascular obstruction
Microvascular obstruction (% left ventricular mass) measured by contrast-enhanced cardiovascular magnetic resonance (CMR) imaging
Measured: 2-5 days after enrolment
Myocardial hemorrhage
Incident myocardial hemorrhage detected by contrast-enhanced cardiovascular magnetic resonance (CMR) imaging
Measured: 2-5 days after enrolment
Left ventricular remodeling
Left ventricular remodeling revealed by left ventricular end-systolic volume index (ml/m2) measured by cardiovascular magnetic resonance (CMR) imaging
Measured: 3 months from baseline
Myocardial blood flow
Global hyperemic blood flow (ml/min/g myocardium) in the anterior wall revealed by adenosine stress perfusion cardiovascular magnetic resonance (CMR) imaging.
Measured: 3 months from baseline
Health-related quality of life
Patient reported outcome measure: EQ-5D-5L is a tool to measure health outcomes with five dimensions and five levels of problems each
Measured: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been qualified by the U.S. Food and Drug Administration as a Clinical Outcome Assessment.
Measured: 12 months
Duke Activity Status Index
The Duke Activity Status Index (DASI) questionnaire is a valid measure of cardiopulmonary fitness.
Measured: 12 months
Serious adverse events
Serious adverse events will be prospectively assessed. The primary criterion for safety monitoring is the incidence of major bleeding events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start25 Oct 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Zoll Medical Corporation, Robertson Centre for Biostatistics - University of Glasgow
- Responsible party
- Principal investigator, Colin Berry, NHS National Waiting Times Centre Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662890
- Sponsor's protocol ID
- 23/CARD/34
- Acronym
- SSO2 Radial MI
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of anonymized data based on sponsor approval.
Publications
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.
PubMed 20031745Falah 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.
PubMed 39132455Chen 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.
PubMed 32649037Shin 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.
PubMed 37676228Carrick 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.
PubMed 27803036Carrick 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.
PubMed 26763281Joshi 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.
PubMed 40510547
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supersaturated Oxygen Therapy Using Radial Artery Access to Prevent Left Ventricular Remodeling After Anterior ST-segment Elevation Myocardial Infarction: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06662890
- Acronym / sponsor ID
- SSO2 Radial MI / 23/CARD/34
- Conditions
- Myocardial Infarct, Remodeling, Left Ventricle
- Keywords
- myocardial infarction, primary percutaneous coronary intervention, heart failure, adverse ventricular remodelling, biomarkers, coronary microvascular function, PREMS, PROMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- British Heart Foundation, Zoll Medical Corporation, Robertson Centre for Biostatistics - University of Glasgow
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2038 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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.
Detailed description
This study is an academic, investigator-initiated clinical trial.
The design involves prospective enrolment of patients with a diagnosis of acute, anterior ST-segment elevation myocardial infarction (STEMI) presenting within 6 hours of symptom and undergoing primary PCI with radial artery acess. The protocol begins after standard, primary percutaneous coronary intervention (PCI). The timepoint for randomization (time zero) is at the end of successful primary PCI. Eligibility criteria include successful completion of primary PCI, defined as TIMI flow grade 2-3 in the left anterior descending coronary artery.
Given that the initial point of urgent/emergency care is in the catheter laboratory, the consent process will involve an initial witnessed verbal informed consent followed by randomization. This approach is in line with prior research in our hospital, contemporary evidence, feedback from experts with lived experience and international practice guidelines [PMID: 37622654 PMID: 32143733]. The Patient Information Sheet and Consent form will be provided to patients and carers on the ward after the angiogram. If the patient agrees to continue in the study then written informed consent will be obtained on the ward.
The study assessments will involve a blood sample, coronary angiography, coronary physiology, cardiovascular magnetic resonance (CMR) imaging scans, health status questionnaires, and electronic case record linkage. If the patient is eligible to participate and agrees to have electronic health record linkage follow-up but no other assessments or procedures, then consent will be invited for electronic health record follow-up only (no visits).
Informed consent will initially be obtained following arrival in the catheter laboratory. Blood samples would be obtained following arterial sheath insertion before PCI (since hemodilution due to the volume of radiographic contrast media may confound the analysis) study begins at the end of standard care primary PCI. Patients who fulfil the eligibility criteria and who have given written witnessed informed assent will be randomly assigned (2:1) to the intervention group or the control group.
Coronary microvascular function will be assessed in all patients at the end of the standard care primary PCI. The diagnostic guidewire should be positioned in the left anterior descending coronary artery using X-ray fluoroscopy. This will be repeated at the end of the intervention / control procedure.
Intervention group SSO2 therapy involves withdrawal of arterial blood, extra-corporeal hyper-oxygenation (ZOLL Circulation Inc console), and infusion of the hyper oxygenated blood into the PCI-treated left anterior descending coronary artery. The hyper oxygenated blood is returned using a standard catheter positioned in the left main coronary artery, via radial artery access. Therefore, temporary radial artery access using one or both radial arteries is needed for the one-hour duration of the SSO2 therapy in the cardiac catheter laboratory. Blinding measures will be implemented, including after returning to the coronary care unit until the end of the study.
Control group To minimize bias, patients assigned to the control group would follow the same schedule as if they were assigned to the intervention group. A control procedure will be undertaken. This procedure will mimic the actual procedure but without additional artery access i.e. no oxygen catheter therapy. The control procedure will involve conscious sedation, local anesthetic given in the usual way in the radial area, manual pressure, activation of the ZOLL Circulation Inc console (without the blood circuit), and then application of the radial closure device. The patient will be cared for by the clinical team in the usual way. The patient will remain blind to treatment group allocation, including after returning to the coronary care unit until the end of the study. Blinding to treatment group assignment will be prospectively documented.
Participants will be followed up with in person contacts up to 1-year post enrolment. Electronic health records may be checked without participant contact into the longer term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supersaturated oxygen therapy using radial artery access | Experimental | Other: Supersaturated oxygenSupersaturated O2 (SSO2) therapy immediately following primary percutaneous coronary intervention using radial artery access in the cardiac catheter laboratory. |
| Control group | Sham comparator | Other: Sham (No Treatment)Control (sham) procedure in addition to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supersaturated oxygenSupersaturated 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 | Supersaturated oxygen therapy using radial artery access |
| Sham (No Treatment)Control (sham) procedure involving wrist manipulation in addition to standard care. | Other | Control group |
Primary outcome
N-terminal pro-B-type natriuretic peptide
Time frame: 3 months from baseline
N-terminal pro-B-type natriuretic peptide plasma concentration, within-subject change post-enrolment during follow-up.
10 secondary outcomes
Coronary microvascular function
Time frame: 2 hours from baseline
Infarct size
Time frame: 2-5 days after enrolment
Microvascular obstruction
Time frame: 2-5 days after enrolment
Myocardial hemorrhage
Time frame: 2-5 days after enrolment
Left ventricular remodeling
Time frame: 3 months from baseline
Myocardial blood flow
Time frame: 3 months from baseline
Health-related quality of life
Time frame: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 12 months
Duke Activity Status Index
Time frame: 12 months
Serious adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 20031745Stone 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.
- Background: PubMed 39132455Falah 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.
- Background: PubMed 32649037Chen 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.
- Background: PubMed 37676228Shin 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.
- Background: PubMed 27803036Carrick 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.
- Background: PubMed 26763281Carrick 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.
- Derived from this study: PubMed 40510547Joshi 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.
- Individual participant dataSharing planned: Yes. Sharing of anonymized data based on sponsor approval.
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Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Henry, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supersaturated oxygen in people with Myocardial Infarct and Remodeling, Left Ventricle, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin Berry, BSc MBChB PhD (441419515180, colin.berry@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-terminal pro-B-type natriuretic peptide (time frame: 3 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662890, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.