Oxygen boost after heart attack shows promise in small study

NCT ID NCT01630707

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to give extra oxygen to the heart after a heart attack. Twenty patients received a special oxygen treatment for one hour through a thin tube placed in the heart artery. The main goal was to see if the procedure was safe and could be done without problems. The study did not test if this treatment cures heart disease, but rather if it could help limit heart damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Start date

Aug 2012

Finished

Aug 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following criteria: Pre-PCI: 1. The subject must be ≥18 and ≤80 years of age. 2. AMI must be anterior. 3. Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration. 4. Signed Informed Consent. 5. Subject agrees to all required follow-up procedures and visits. 6. Negative pregnancy test for women of childbearing potential. ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment: 7. PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD. 8. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery. 9. Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD. 10. Successful angioplasty and no major complications such as perforation or shock. 11. Expected ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system to deliver SSO2 Therapy with stable, coaxial alignment. 12. Planned revascularization of a non-target lesion is allowed. Patients will be excluded if ANY of the following conditions apply: GENERAL EXCLUSION CRITERIA Pre-PCI: 13. Prior CABG surgery. 14. Prior myocardial infarction, or known prior systolic dysfunction. 15. Thrombolytic therapy administered for this STEMI. 16. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment. 17. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI. 18. Subjects who have previously undergone angioplasty or stenting in the LAD. 19. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation. 20. Any contraindication to undergo MRI imaging. 21. Impaired renal function or on dialysis. 22. Known platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a known Hgb \<10 g/dL. 23. Subject has active bleeding or a history of bleeding. 24. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke. 25. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect. 26. Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment. 27. Subject has received any organ transplant or is on a waiting list for any organ transplant. 28. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that a may cause non-compliance with the protocol. 29. Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated. 30. Current use of warfarin, dabigatran, or factor Xa inhibitors. 31. Subjects presenting with or developing in the cath lab: cardiogenic shock or ventricular fibrillation or tachycardia. 32. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy. 33. Any significant medical condition which in the investigator's opinion may interfere with the subject's optimal participation in the study. 34. Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period. 35. Previous enrollment in this study. ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment: 36. Inability to achieve a stable coaxial position in the left main coronary artery with the catheter. 37. Treatment during the index procedure of any lesion in the left main, LCX, and/or RCA. 38. Coronary anatomy such that coronary artery bypass graft surgery is indicated within 30 days. 39. Post-index procedure planned intervention within 30 days. 40. Anatomic features are present which are highly unfavorable for PCI. 41. Anterior MI is due to thrombosis within or adjacent to a previously implanted stent. 42. Left ventriculography demonstrates severe mitral regurgitation, a ventricular septal defect, or a pseudoaneurysm. 43. Any left main coronary artery stenosis \>20%. 44. Any untreated LAD or diagonal branch lesion is present with diameter stenosis \>= 50% in a vessel with reference vessel diameter \> 2.0 mm or for which PCI will be required before the MRI study. 45. Presence of a non-stented coronary dissection upon completion of the PCI procedure.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan, 48703, United States

  • Providence Hospital and Medical Centers

    Southfield, Michigan, 48075, United States

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85259, United States

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660, United States