The RECOVERY Study: Using Supersaturated Oxygen Therapy To Treat Small Vessel Blockages After a Heart Attack
NCT07000266 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-06-02
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.
Conditions
- Anterior STEMI
Interventions
- PROCEDURE
-
Percutaneous Coronary Intervention (PCI)
Standard PCI intervention
- DIAGNOSTIC_TEST
-
Diagnostic Imaging
Cardiac Magnetic Ressonance (CMR) and hospital discharge
- DEVICE
-
Device Treatment
SSO2 therapy
- PROCEDURE
-
Follow-up at 30 days
Remote (phone) follow-up at 30 days
- PROCEDURE
-
Follow-up at 60 days
In person follow-up at 60 days
- PROCEDURE
-
Follow-up at 12 months
Remote (phone) follow-up at 12 months
Sponsors & Collaborators
-
Zoll Medical Corporation
collaborator INDUSTRY -
Fundacio Privada Mon Clinic Barcelona
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-23
- Primary Completion
- 2027-05-16
- Completion
- 2027-12-31
Countries
- Spain
Study Locations
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