An interventional study of Percutaneous Coronary Intervention (PCI) and Diagnostic Imaging in Anterior STEMI, sponsored by Fundacio Privada Mon Clinic Barcelona. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-02.
Sponsored by Fundacio Privada Mon Clinic Barcelona · Not applicable, Interventional, and Treatment
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.
This is an investigator-initiated, post-market clinical investigation, interventional, prospective, randomized, controlled, open-label, monocenter study, in subjects with anterior STEMI with two parallel arms comparing the efficacy of SSO2 with standard PCI and standard PCI alone on reduction of microvascular resistances (Rµ)
Patients will be ≥ 18 years old and diagnosed with a first anterior STEMI requiring stent placement, symptoms duration of ≤ 6 hours and culprit lesion in the left anterior descending (LAD) artery with a TIMI (Thrombolysis In Myocardial Infarction) flow 0 or 1 without collateral circulation.
Patients who provide informed consent will be treated with primary PCI with stenting. Once the coronary blood flow is re-established, and after general and angiographic inclusion and exclusion criteria are confirmed, patients will be randomized and enrolled in the study.
A total number of 20 patients will be randomized (1:1) to SSO2 plus PCI arm or standard PCI control arm. Once randomized, SSO2 arm patients will receive SSO2 therapy inside the catheterization laboratory, meanwhile patients randomized in the standard arm will not receive further treatment beyond standard of care.
For both arms, coronary invasive measurements will be performed immediately and 60 minutes after coronary blood flow restoration and then at 6 months timepoint. Baseline clinical and procedural variables will be collected. There will be a clinical follow-up at 30 days ± 7 days, 6 months ± 1 month and 1 year ± 1 month after index event.
667 studies on the registry are indexed under ST Elevation Myocardial Infarction; 180 are open to participants now.
This study's planned enrollment of 20 is below the median of 194 across 427 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Fundacio Privada Mon Clinic Barcelona is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment group
Procedure: Percutaneous Coronary Intervention (PCI) · Diagnostic Test: Diagnostic Imaging · Device: Device Treatment · Procedure: Follow-up at 30 days · Procedure: Follow-up at 60 days · Procedure: Follow-up at 12 months
Control group
Procedure: Percutaneous Coronary Intervention (PCI) · Diagnostic Test: Diagnostic Imaging · Procedure: Follow-up at 30 days · Procedure: Follow-up at 60 days · Procedure: Follow-up at 12 months
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
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)
Time frame: 60 minutes after primary PCI
Effect of SSO2 on absolute coronary flow (Q)
Absolute coronary flow (Q): difference in Q, between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Time frame: At 60 minutes and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Microvascular resistances (Rµ): difference in (Rµ) between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Time frame: 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)
Index of microvascular resistance (IMR): difference in IMR between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Time frame: 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)
Coronary flow reserve (CFR): difference in CFR between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Time frame: 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)
Microvascular resistance reserve (MRR): difference in MRR between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Time frame: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on infarct size and microvascular obstruction at CMR
Quantification of infarct size as a percentage of left ventricular mass using late gadolinium enhancement (LGE) and assessment of microvascular obstruction (MVO) presence and extent.
Time frame: At CMR 3-5 days after primary PCI
Risk of predefined major cardiovascular adverse events (MACE) during treatment and follow-up
Time from randomization to the first occurrence of any event in the predefined MACE composite per patient.
Time frame: During treatment, during follow-up at 30 days, 60 days and 12 months follow-ups
Risk of predefined major cardiovascular adverse events (MACE) during treatment and follow-up
Per-patient rate of composite MACE events (first and subsequent)
Time frame: At at 30 days, 6 months and 1 year follow-ups after index PCI
Effect of SSO2 on ventricular remodeling
Proportion of patients with adverse ventricular remodeling, defined as a Δ ≥20% in end-diastolic volume (EDV) or a Δ ≥15% in end-systolic volume (ESV), with additional assessment of myocardial tissue characteristics using T2-weighted imaging and LGE.
Time frame: From baseline to follow-up CMR
Effect of SSO2 on left ventricular hypertrophy
Proportion of patients with left ventricular hypertrophy in the SSO2 therapy arm compared to the standard PCI control arm, as assessed by CMR. Left ventricular hypertrophy is considered for masses above 106.2 g/m2 for men and 84.6 g/m2 in women
Time frame: At CMR 3-5 days after primary PCI
Plan to share: No
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ST Elevation Myocardial Infarction→
Fundacio Privada Mon Clinic Barcelona