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STEMIIC-HOT-MICRONCT05790876

Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction

A study testing SSO2 therapy in people with STEMI and Coronary Microvascular Dysfunction, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to demonstrate the improvement in Coronary Microcirculation Dysfunction (CMD) with Super Saturated Oxygene (SSO2) therapy in patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) successfully revascularized by percutaneous coronary intervention (PCI). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
STEMI, Coronary Microvascular Dysfunction
What is being tested?
SSO2 therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
21 Mar 2023to 11 Jun 2025
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years and <80 years
  • ST-segment elevation myocardial infarction within 6 hours of symptom onset with ≥1 mm ST-segment elevation in ≥2 contiguous leads in V1-V4 or new left bundle branch block.
  • Successful PCI of a proximal or medial LAD lesion with commercially available coronary stents and achievement of residual stenosis <50% diameter and thrombolysis-in-myocardial-infarction (TIMI) flow grade 2 or 3.
  • Systemic arterial pO2 greater than or equal to 10.7 kPa or 80 mmHg with or without oxygen supplementation.
  • Patient enrolled in a social security plan or beneficiary of such a plan
  • Consent obtained from the patient before inclusion (Emergency consent)

Who cannot join

  • History of anterior coronary artery bypass grafting (CABG)
  • Previous myocardial infarction
  • History of PCI on the LAD
  • New LAD PCI planned within 30 days.
  • Mechanical complications of STEMI (Patients with ventricular pseudoaneurysm, ventricular septal defect (VSD), or severe mitral valve regurgitation (with or without papillary muscle rupture)), cardiogenic shock, or Presence of an intra-aortic counterpulsation balloon.
  • Valvular stenosis or heart failure, pericardial disease, or nonischemic cardiomyopathy.
Show all 15Show fewer
  • Known prior left ventricular ejection fraction (LVEF) < 40%,
  • Use of thrombolytic therapy
  • Patients with a contraindication to anticoagulant therapy.
  • Creatinine clearance <30 ml/min/1.73 m2,
  • Hemoglobin <10 g/dL
  • Gastrointestinal or urogenital bleeding within the last two months or any major surgery (including CABG) within six weeks prior to surgery.
  • Female of childbearing age
  • Patient on deferral or participating in another clinical investigation,
  • Protected populations: pregnant women, parturients, nursing mothers; persons deprived of liberty by a judicial or administrative decision; protected adults

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital Grenoble

    La Tronche, 38700

Other trials in France

About this study

Official title: Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculatory Dysfunction: Pilot Study

The goal of this clinical trial is to demonstrate the improvement in Coronary Microcirculation Dysfunction (CMD) with Super Saturated Oxygene (SSO2) therapy in patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) successfully revascularized by percutaneous coronary intervention (PCI).

Participants will receive SSO2 therapy for 60 minutes, which aims to overoxygenate their blood. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images.

Read the detailed description

Ten patients with acute anterior STEMI undergoing primary PCI will be enrolled. After successful PCI of a proximal lesion or middle left anterior descending artery (LAD), the patient will be informed and emergency consent will be obtained.

SSO2 therapy will then be performed. Blood is drawn from a femoral artery sheath and circulated via a roller pump through an extracorporeal oxygenator located in a polycarbonate chamber to achieve a PaO2 of 760 to 1000 mmHg. The overoxygenated blood is then delivered to the origin of the LAD at a flow rate of 100 ml/min for 60 minutes via a dedicated catheter.

Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images. Then, conventional follow-up of previous STEMI will be performed by imaging and functional assessment.

The primary endpoint will be analyzed using a paired Student's t test, to take into account the evolution "before/after" implementation of SSO2 therapy on CMD.

The demonstration of the beneficial effect of SSO2 therapy on CMD will allow the development of a care strategy based on CMD measurement by angio-IMR. Thus, this new treatment could be reserved for patients with severe CMD for which our management arsenal is still lacking, even though we know that CMD is a major prognostic factor in STEMI patients.

Being tested
SSO2 therapy
Keywords
STEMI, coronary microcirculatory dysfunction, SSO2 therapy
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSO2 therapyProcedure or surgery

    SSO2 therapy consists of overoxygenating the patient's blood and delivering it to the origin of the LAD for 60 min. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images

Study groups in NCT05790876
Study groupRoleWhat they receive
SSO2 therapyExperimentalAfter successful PCI of a proximal or middle LAD lesion, the patient will be informed and emergency consent will be obtained. SSO2 therapy will then be performed. Overoxygenated blood will be delivered to the origin of the LAD for 60 minutes. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images
Receives: Procedure: SSO2 therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angio-IMR measurement before and after treatment with SSO2 therapy

    Angio-IMR measurement before and after treatment with SSO2 therapy to demonstrate improvement in CMD with SSO2 therapy in patients with anterior STEMI successfully revascularized by PCI

    Measured: Maximum 7 hours after symptoms

Secondary outcomes (4)

  1. 30-day composite rate of net clinical adverse events (death, reinfarction, target vessel revascularization, stent thrombosis, severe heart failure or major/minor bleeding TIMI classification

    30-day composite criterion rate

    Measured: 30 days

  2. Measurement of exercise performance

    Number of watts per exercise test at the end of cardiovascular rehabilitation

    Measured: 3 months

  3. Reversal of cardiac remodeling

    Baseline and 3-month echocardiography. Left Ventricle (LV) remodeling is defined as an increase ≥20% in LV end-diastolic volume at 3 months after infarction.

    Measured: Baseline and 3 months

  4. Late gadolinium enhancement by cardiac MRI to measure the infarct size

    Measurement of infarct size

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start21 Mar 2023
  3. Primary completion7 Mar 2025
  4. Study completion11 Jun 2025

Resources

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
Not applicable
Intervention model
Single group
Model description
Prospective, single-center, non-controlled, non-randomized, open-label study (pilot study)
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05790876
Sponsor's protocol ID
38RC22.0268
Other IDs
2022-A02380-43
Acronym
IC-HOT-MICRO
Status last verified
Jun 2025
First submitted
28 Feb 2023
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Roth GA, Johnson C, Abajobir A, Abd-Allah F, Abera SF, Abyu G, Ahmed M, Aksut B, Alam T, Alam K, Alla F, Alvis-Guzman N, Amrock S, Ansari H, Arnlov J, Asayesh H, Atey TM, Avila-Burgos L, Awasthi A, Banerjee A, Barac A, Barnighausen T, Barregard L, Bedi N, Belay Ketema E, Bennett D, Berhe G, Bhutta Z, Bitew S, Carapetis J, Carrero JJ, Malta DC, Castaneda-Orjuela CA, Castillo-Rivas J, Catala-Lopez F, Choi JY, Christensen H, Cirillo M, Cooper L Jr, Criqui M, Cundiff D, Damasceno A, Dandona L, Dandona R, Davletov K, Dharmaratne S, Dorairaj P, Dubey M, Ehrenkranz R, El Sayed Zaki M, Faraon EJA, Esteghamati A, Farid T, Farvid M, Feigin V, Ding EL, Fowkes G, Gebrehiwot T, Gillum R, Gold A, Gona P, Gupta R, Habtewold TD, Hafezi-Nejad N, Hailu T, Hailu GB, Hankey G, Hassen HY, Abate KH, Havmoeller R, Hay SI, Horino M, Hotez PJ, Jacobsen K, James S, Javanbakht M, Jeemon P, John D, Jonas J, Kalkonde Y, Karimkhani C, Kasaeian A, Khader Y, Khan A, Khang YH, Khera S, Khoja AT, Khubchandani J, Kim D, Kolte D, Kosen S, Krohn KJ, Kumar GA, Kwan GF, Lal DK, Larsson A, Linn S, Lopez A, Lotufo PA, El Razek HMA, Malekzadeh R, Mazidi M, Meier T, Meles KG, Mensah G, Meretoja A, Mezgebe H, Miller T, Mirrakhimov E, Mohammed S, Moran AE, Musa KI, Narula J, Neal B, Ngalesoni F, Nguyen G, Obermeyer CM, Owolabi M, Patton G, Pedro J, Qato D, Qorbani M, Rahimi K, Rai RK, Rawaf S, Ribeiro A, Safiri S, Salomon JA, Santos I, Santric Milicevic M, Sartorius B, Schutte A, Sepanlou S, Shaikh MA, Shin MJ, Shishehbor M, Shore H, Silva DAS, Sobngwi E, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadele Atnafu N, Tesfay F, Thakur JS, Thrift A, Topor-Madry R, Truelsen T, Tyrovolas S, Ukwaja KN, Uthman O, Vasankari T, Vlassov V, Vollset SE, Wakayo T, Watkins D, Weintraub R, Werdecker A, Westerman R, Wiysonge CS, Wolfe C, Workicho A, Xu G, Yano Y, Yip P, Yonemoto N, Younis M, Yu C, Vos T, Naghavi M, Murray C. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015. J Am Coll Cardiol. 2017 Jul 4;70(1):1-25. doi: 10.1016/j.jacc.2017.04.052. Epub 2017 May 17.

    PubMed 28527533

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

    PubMed 28886621

  • Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labeque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrieres J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.

    PubMed 31181374

  • Bouisset F, Ruidavets JB, Dallongeville J, Moitry M, Montaye M, Biasch K, Ferrieres J. Comparison of Short- and Long-Term Prognosis between ST-Elevation and Non-ST-Elevation Myocardial Infarction. J Clin Med. 2021 Jan 7;10(2):180. doi: 10.3390/jcm10020180.

    PubMed 33430516

  • Jenca D, Melenovsky V, Stehlik J, Stanek V, Kettner J, Kautzner J, Adamkova V, Wohlfahrt P. Heart failure after myocardial infarction: incidence and predictors. ESC Heart Fail. 2021 Feb;8(1):222-237. doi: 10.1002/ehf2.13144. Epub 2020 Dec 14.

    PubMed 33319509

  • Del Buono MG, Montone RA, Camilli M, Carbone S, Narula J, Lavie CJ, Niccoli G, Crea F. Coronary Microvascular Dysfunction Across the Spectrum of Cardiovascular Diseases: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Sep 28;78(13):1352-1371. doi: 10.1016/j.jacc.2021.07.042.

    PubMed 34556322

  • Niccoli G, Scalone G, Lerman A, Crea F. Coronary microvascular obstruction in acute myocardial infarction. Eur Heart J. 2016 Apr 1;37(13):1024-33. doi: 10.1093/eurheartj/ehv484. Epub 2015 Sep 12.

    PubMed 26364289

  • Maznyczka AM, Oldroyd KG, McCartney P, McEntegart M, Berry C. The Potential Use of the Index of Microcirculatory Resistance to Guide Stratification of Patients for Adjunctive Therapy in Acute Myocardial Infarction. JACC Cardiovasc Interv. 2019 May 27;12(10):951-966. doi: 10.1016/j.jcin.2019.01.246.

    PubMed 31122353

  • Canu M, Khouri C, Marliere S, Vautrin E, Piliero N, Ormezzano O, Bertrand B, Bouvaist H, Riou L, Djaileb L, Charlon C, Vanzetto G, Roustit M, Barone-Rochette G. Prognostic significance of severe coronary microvascular dysfunction post-PCI in patients with STEMI: A systematic review and meta-analysis. PLoS One. 2022 May 16;17(5):e0268330. doi: 10.1371/journal.pone.0268330. eCollection 2022.

    PubMed 35576227

  • Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027.

    PubMed 34353599

  • Kloner RA, Creech JL, Stone GW, O'Neill WW, Burkhoff D, Spears JR. Update on Cardioprotective Strategies for STEMI: Focus on Supersaturated Oxygen Delivery. JACC Basic Transl Sci. 2021 Oct 27;6(12):1021-1033. doi: 10.1016/j.jacbts.2021.07.011. eCollection 2021 Dec.

    PubMed 35024508

  • 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 20031745

  • O'Neill WW, Martin JL, Dixon SR, Bartorelli AL, Trabattoni D, Oemrawsingh PV, Atsma DE, Chang M, Marquardt W, Oh JK, Krucoff MW, Gibbons RJ, Spears JR; AMIHOT Investigators. Acute Myocardial Infarction with Hyperoxemic Therapy (AMIHOT): a prospective, randomized trial of intracoronary hyperoxemic reperfusion after percutaneous coronary intervention. J Am Coll Cardiol. 2007 Jul 31;50(5):397-405. doi: 10.1016/j.jacc.2007.01.099. Epub 2007 Jul 16.

    PubMed 17662390

  • Hanson ID, David SW, Dixon SR, Metzger DC, Genereux P, Maehara A, Xu K, Stone GW. "Optimized" delivery of intracoronary supersaturated oxygen in acute anterior myocardial infarction: a feasibility and safety study. Catheter Cardiovasc Interv. 2015 Oct;86 Suppl 1:S51-7. doi: 10.1002/ccd.25773. Epub 2015 Apr 2.

    PubMed 25512256

  • David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28.

    PubMed 30265429

Questions about this trial

What is this clinical trial studying?

A study testing SSO2 therapy in people with STEMI and Coronary Microvascular Dysfunction, run by University Hospital, Grenoble at 1 site in France.

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 15 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: finished, as of the sponsor's last update on 17 Jun 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 France. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Angio-IMR measurement before and after treatment with SSO2 therapy (time frame: Maximum 7 hours after symptoms). 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 NCT05790876, which also lists 21 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 17 Jun 2025.

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