Myocardial Infarction (MI)HOT-AAMINCT06742684
Hyperoxemic Oxygen Therapy in Patients With Acute Anterior Myocardial Infarction
A study testing PCI with following SSO2 Therapy in people with Myocardial Infarction (MI), run by IHF GmbH - Institut für Herzinfarktforschung.
Trial summary
The HOT-AAMI study investigates the efficacy of supersaturated oxygen therapy (SSO2) as an adjunct to standard percutaneous coronary intervention (PCI) with stent implantation in patients suffering from acute anterior myocardial infarction (AMI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction (MI)
- What is being tested?
- PCI with following SSO2 Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Age ≥18 years
- Presence of an acute anterior wall infarction with ST-segment elevation ≥ 1mm in two or more contiguous leads V1 - V4, or newly developed left bundle branch block
- Symptom duration ≤6 hours
- Systemic arterial oxygen partial pressure (pO2) of at least 10.7 kPa or 80 mmHg
- Written informed consent, or procedures following Article 68 MDR Clinical Trials in emergencies
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- Angiographic Inclusion Criteria:
- These criteria are assessed after the study participant has signed the informed consent form and coronary angiography and PCI have been performed.
- Successful PCI of the proximal or middle LAD (left anterior descending artery). Success is defined as a residual stenosis of <50% in all treated culprit lesions with a TIMI flow (Thrombolysis in Myocardial Infarction) of ≥2 in the target vessel.
Who cannot join
- General Exclusion Criteria:
- Previous coronary bypass surgery involving the LAD
- Previous anterior wall infarction with known ischemic cardiomyopathy
- Active bleeding, bleeding diathesis, or a history of coagulopathy (including heparin-induced thrombocytopenia)
- Known intracerebral tumor, aneurysm, arteriovenous malformation, or a history of hemorrhagic stroke
- Known prior organ transplantation or on the waiting list
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- Severe mitral regurgitation, ventricular septal defect, ischemic myocardial rupture, or other mechanical complications of acute myocardial infarction
- Acute aortic dissection
- Known severe valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy
- The patient belongs to a particularly vulnerable population or suffers from a significant medical or social condition that, in the investigator's opinion, could impair the patient's ability to participate in the study or comply with follow-up procedures (e.g., alcoholism, dementia, living far from the study site, etc.)
- Current participation in another study involving an investigational product or drug
- Patients who develop any of the following complications in the catheterization lab before completing the PCI procedure: cardiogenic shock (systolic blood pressure: SBP less than 80 mmHg for more than 30 minutes), emergency placement of an intra-aortic balloon pump (IABP), an Impella pump, or ECMO (extracorporeal membrane oxygenation), or cardiopulmonary resuscitation for > 10 minutes.
- Angiographic Exclusion Criteria:
- Left main coronary artery stenosis more than 80%.
About this study
The HOT-AAMI study investigates the efficacy of supersaturated oxygen therapy (SSO2) as an adjunct to standard percutaneous coronary intervention (PCI) with stent implantation in patients suffering from acute anterior myocardial infarction (AMI). This is a prospective, open-label, multicenter, two-arm, randomized (1:1) clinical trial conducted in Germany.
Objective:
Read more
The primary aim is to assess whether SSO2 therapy reduces the risk of mortality and heart failure progression after PCI compared to PCI alone. Secondary endpoints include cardiac morbidity, quality of life (Kansas City Cardiomyopathy Questionnaire), and adverse events over 12 months.
Study Design:
The trial involves 1,266 patients randomized to receive either the SSO2 therapy post-PCI or PCI alone. Participants must be adults with acute anterior AMI and undergo successful PCI within 6 hours of symptom onset. Recruitment is expected to span 36 months with a follow-up period of 12 months for each participant.
Intervention and Control:
Intervention group: SSO2 therapy delivered intracoronary using hyperoxygenated blood.
Control group: Standard PCI with stent placement without adjunctive therapy.
Primary Endpoint:
The combined outcome of all-cause mortality or unplanned hospital/ambulatory visits for heart failure requiring intravenous diuretics within 12 months post-randomization.
Background and Rationale:
AMI treatment often leaves significant myocardial damage despite successful PCI. Prior studies on SSO2 therapy have demonstrated potential benefits, including reduced infarct size and improved myocardial function, with evidence suggesting reduced heart failure rates and improved long-term survival.
Statistical Power:
The study anticipates a primary endpoint event rate of 16% in the control group, with a hypothesized hazard reduction of 25% in the intervention group. A total of 393 events across 1,266 patients are needed to achieve an 80% power at a 5% significance level.
Safety and Monitoring:
A Data Safety Monitoring Board (DSMB) will oversee the trial. Adverse events will be documented and reported according to protocol guidelines.
Expected Outcomes:
If successful, the study may provide evidence for integrating SSO2 therapy into clinical practice, potentially lowering mortality and morbidity in AMI patients, with implications for both patient care and healthcare costs.
- Conditions
- Myocardial Infarction (MI)
- Being tested
- PCI with following SSO2 Therapy
- Keywords
- AMI, PCI, Hyperoxemic Therapy
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI with following SSO2 TherapyProcedure or surgery
SSO2 Therapy
| Study group | Role | What they receive |
|---|---|---|
| Only PCI | No intervention | Patients only will receive a PCI according to standard of care |
| PCI with following SSO2 Therapy | Experimental | Patient receive a PCI according to standard of care. Additionally patients in this arm will be treated right after the PCI with the SSO2 Therapy Receives: Procedure: PCI with following SSO2 Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality or unplanned heart failure hospital admission or unplanned outpatient visit due to heart failure requiring intravenous diuretic therapy
Measured: 12 months after the last patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study startMay 2025 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Why it stopped: The study could not be started due to a lack of funding for the provision of the medical product to be investigated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction (MI)Studies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uwe Zeymer, Prof Dr, Principal investigator, IHF GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742684
- Sponsor's protocol ID
- BO-001
- Acronym
- HOT-AAMI
- Status last verified
- Jun 2025
- First submitted
- 13 Dec 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeymer U, Hassinger F, Bramlage P, Schafer A, Westermann D, Thiele H; HOT-AAMI Investigators. Hyperoxemic oxygen therapy in patients with acute anterior myocardial infarction: HOT-AAMI-design and rationale of a randomized trial. Am Heart J. 2025 Aug;286:35-44. doi: 10.1016/j.ahj.2025.03.013. Epub 2025 Mar 21.
PubMed 40122364
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxemic Oxygen Therapy in Patients With Acute Anterior Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06742684
- Acronym / sponsor ID
- HOT-AAMI / BO-001
- Conditions
- Myocardial Infarction (MI)
- Keywords
- AMI, PCI, Hyperoxemic Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study could not be started due to a lack of funding for the provision of the medical product to be investigated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Dec 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.
The HOT-AAMI study investigates the efficacy of supersaturated oxygen therapy (SSO2) as an adjunct to standard percutaneous coronary intervention (PCI) with stent implantation in patients suffering from acute anterior myocardial infarction (AMI). This is a prospective, open-label, multicenter, two-arm, randomized (1:1) clinical trial conducted in Germany.
Objective:
The primary aim is to assess whether SSO2 therapy reduces the risk of mortality and heart failure progression after PCI compared to PCI alone. Secondary endpoints include cardiac morbidity, quality of life (Kansas City Cardiomyopathy Questionnaire), and adverse events over 12 months.
Study Design:
The trial involves 1,266 patients randomized to receive either the SSO2 therapy post-PCI or PCI alone. Participants must be adults with acute anterior AMI and undergo successful PCI within 6 hours of symptom onset. Recruitment is expected to span 36 months with a follow-up period of 12 months for each participant.
Intervention and Control:
Intervention group: SSO2 therapy delivered intracoronary using hyperoxygenated blood.
Control group: Standard PCI with stent placement without adjunctive therapy.
Primary Endpoint:
The combined outcome of all-cause mortality or unplanned hospital/ambulatory visits for heart failure requiring intravenous diuretics within 12 months post-randomization.
Background and Rationale:
AMI treatment often leaves significant myocardial damage despite successful PCI. Prior studies on SSO2 therapy have demonstrated potential benefits, including reduced infarct size and improved myocardial function, with evidence suggesting reduced heart failure rates and improved long-term survival.
Statistical Power:
The study anticipates a primary endpoint event rate of 16% in the control group, with a hypothesized hazard reduction of 25% in the intervention group. A total of 393 events across 1,266 patients are needed to achieve an 80% power at a 5% significance level.
Safety and Monitoring:
A Data Safety Monitoring Board (DSMB) will oversee the trial. Adverse events will be documented and reported according to protocol guidelines.
Expected Outcomes:
If successful, the study may provide evidence for integrating SSO2 therapy into clinical practice, potentially lowering mortality and morbidity in AMI patients, with implications for both patient care and healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Only PCI | No intervention | –Patients only will receive a PCI according to standard of care |
| PCI with following SSO2 Therapy | Experimental | Procedure: PCI with following SSO2 TherapyPatient receive a PCI according to standard of care. Additionally patients in this arm will be treated right after the PCI with the SSO2 Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Presence of an acute anterior wall infarction with ST-segment elevation ≥ 1mm in two or more contiguous leads V1 - V4, or newly developed left bundle branch block
- Symptom duration ≤6 hours
- Systemic arterial oxygen partial pressure (pO2) of at least 10.7 kPa or 80 mmHg
- Written informed consent, or procedures following Article 68 MDR Clinical Trials in emergencies
Key exclusion criteria (14 listed)
- Previous coronary bypass surgery involving the LAD
- Previous anterior wall infarction with known ischemic cardiomyopathy
- Active bleeding, bleeding diathesis, or a history of coagulopathy (including heparin-induced thrombocytopenia)
- Known intracerebral tumor, aneurysm, arteriovenous malformation, or a history of hemorrhagic stroke
- Known prior organ transplantation or on the waiting list
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 |
|---|---|---|
| PCI with following SSO2 TherapySSO2 Therapy | Procedure or surgery | PCI with following SSO2 Therapy |
Primary outcome
all-cause mortality or unplanned heart failure hospital admission or unplanned outpatient visit due to heart failure requiring intravenous diuretic therapy
Time frame: 12 months after the last patient is enrolled
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 40122364Zeymer U, Hassinger F, Bramlage P, Schafer A, Westermann D, Thiele H; HOT-AAMI Investigators. Hyperoxemic oxygen therapy in patients with acute anterior myocardial infarction: HOT-AAMI-design and rationale of a randomized trial. Am Heart J. 2025 Aug;286:35-44. doi: 10.1016/j.ahj.2025.03.013. Epub 2025 Mar 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Uwe Zeymer, Prof Dr principal investigator
IHF GmbH
Questions about this trial
What is this clinical trial studying?
A study testing PCI with following SSO2 Therapy in people with Myocardial Infarction (MI), run by IHF GmbH - Institut für Herzinfarktforschung.
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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality or unplanned heart failure hospital admission or unplanned outpatient visit due to heart failure requiring intravenous diuretic therapy (time frame: 12 months after the last patient is enrolled). 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 NCT06742684, which also lists 1 linked publication.
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 8 Jun 2025.