The RECOVERY Study: Using Supersaturated Oxygen Therapy To Treat Small Vessel Blockages After a Heart Attack
Recovering Coronary Microvascular Obstruction With Supersaturated Oxygen Therapy in ST-segment Elevation Myocardial Infarction (STEMI) Patients: The RECOVERY Study
1 other identifier
interventional
20
1 country
1
Brief Summary
The study tests whether adding supersaturated oxygen (SSO₂) therapy to standard stent treatment can improve heart recovery after a major heart attack (anterior STEMI). Adults treated within 6 hours of symptoms will be randomly assigned to receive either standard care or standard care plus SSO₂. The goal is to see if SSO₂ reduces damage to small heart vessels. Heart function will be checked immediately, after one hour, and again at six months. Follow-up visits will track recovery for up to a year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 2, 2025
May 1, 2025
2 years
May 8, 2025
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of SSO2 on microvascular resistances (Rµ)
Superiority in % of patients without microvascular dysfunction (defined as microvascular resistance \>500 WU) of SSO2 arm versus standard of care (90% of patients with microvascular dysfunction in the control arm vs. 30% in the SSO2 arm)
60 minutes after primary PCI
Secondary Outcomes (8)
Effect of SSO2 on absolute coronary flow (Q)
At 60 minutes and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on the coronary flow reserve (CFR)
Within 5 minutes after primary PCI, at 60 minutes after PCI and at 6 months after primary PCI
Effect of SSO2 on the microvascular resistance reserve (MRR)
Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
- +3 more secondary outcomes
Other Outcomes (2)
Effect of SSO2 on ventricular remodeling
From baseline to follow-up CMR
Effect of SSO2 on left ventricular hypertrophy
At CMR 3-5 days after primary PCI
Study Arms (2)
Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy
EXPERIMENTALTreatment group
Standard Percutaneous Coronary Intervention (PCI)
EXPERIMENTALControl group
Interventions
Standard PCI intervention
Cardiac Magnetic Ressonance (CMR) and hospital discharge
SSO2 therapy
Remote (phone) follow-up at 30 days
In person follow-up at 60 days
Remote (phone) follow-up at 12 months
Eligibility Criteria
You may qualify if:
- The subject must be ≥ 18 years of age
- Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
- Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 6 hours.
- Provision of informed consent by patient
- Culprit lesion in proximal or mid LAD.
- Pre-PCI TIMI flow 0-1.
- The patient is eligible for primary PCI.
- Successful PCI of a proximal or mid LAD lesion with commercially available coronary stents and achievement of TIMI 2 or 3 flow
- Expected ability to place the catheter in the left main coronary ostium to deliver SSO2 therapy with stable and coaxial alignment.
You may not qualify if:
- Previous MI, PCI or CABG occurred before index procedure.
- Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
- Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
- Known coagulopathy.
- Known ongoing anticoagulant treatment.
- Known large pericardial effusion or cardiac tamponade.
- Known allergies to polyurethanes, PET or stainless steel.
- Unconscious at presentation.
- Need for circulatory support.
- Need for invasive mechanical ventilation.
- Need for temporal intravenous pacemaker.
- Cardiopulmonary resuscitation (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
- Patients confirmed as pregnant.
- Active participation in another drug or device investigational trial.
- Known contraindication for adenosine administration (severe asthma, complicated AV block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacio Privada Mon Clinic Barcelonalead
- Zoll Medical Corporationcollaborator
Study Sites (1)
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2025
First Posted
June 2, 2025
Study Start
May 23, 2025
Primary Completion (Estimated)
May 16, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 2, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share