Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT07000266
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.
Detailed Description:
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.
Study:
NCT07000266
Study Brief:
Protocol Section:
NCT07000266