Randomised EValuation of Therapies for microvAscuLar Injury in STEACS
ConditionSTEMI (ST Elevation MI)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorFlow Therapeutics AG
About this trial
The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control.
The targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care.
Enrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months.
If detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).
Eligibility criteria
Qualifiers
Subjects age ≥18 years old
Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process
Infarct-related lesion in proximal or mid left anterior descending coronary artery
ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
Disqualifiers
Unconscious on presentation
Patients under judicial protection, legal guardianship or curatorship
Mental disorder or language barrier that precludes informed assent/consent GCP, governing regulations and approved process
Known severe kidney disease (estimated glomerular filtration rate (eGFR) < 30 ml/min) or on haemodialysis
Trial design
Treatments tested in this trial
- Therapeutic sequence
- Diagnostic sequence
Treatment groups
250 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov