WithdrawnNot Applicable

STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)

Stopped: due to COVID repercussions

0Started 2020-02-20

Plain-language summary

A Multicenter, Prospective, Randomized-Controlled Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients with Acute Myocardial Infarction. The Phase A portion of the trial will include 80 enrollments from up to 15 sites.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient is \>= 18 years of age.
✓. The patient must have symptoms consistent with AMI (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 60 minutes but less than 4.5 hours prior to presentation at Hospital.
✓. Evidence of Acute Anterior MI with ST-segment elevation of \>= 0.2 mV in two or more anterior contiguous precordial leads (V1-V4), as confirmed by ECG at baseline.
✓. The patient is eligible for primary PCI.
✓. The patient's condition and site workflow allow for the feasibility of implementing the cooling protocol within trial protocol specific requirements.
✓. The patient or patient's legal representative is willing to provide written, informed consent to participate in this clinical trial.

Exclusion criteria

✕. The patient has had a previous myocardial infarction.
✕. The patient is experiencing cardiogenic shock, systolic blood pressure \[SBP\] \<100 mmHg, HR\>100 bpm and arterial oxygen saturation (pulse oximetry) \<= 92% without additional oxygen.
✕. The patient has known history of Congestive Heart Failure (CHF), hepatic failure, end stage kidney disease or severe renal failure (clearance \< 30ml/min/1.73m²).
✕. The patient is presenting with resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class III through IV.
✕. The patient has an aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
✕. The patient is febrile (temperature \> 37.5 °C) or has experienced any infection in the last 5 days.
✕. The patient has a known previous CABG.
✕. The patient has a known recent stroke within 90 days of admission.

What they're measuring

Phase A Safety Endpoint: Incidence of MACE at 30 days.

Timeframe: Through study completion, approximately 1 year

Phase A Device Performance Endpoint: Proportion of cooled patients who reach ≤34° at PCI.

Timeframe: Through study completion, approximately 1 year

Trial details

NCT IDNCT03361995

SponsorZOLL Circulation, Inc., USA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-12

View on ClinicalTrials.gov More Acute Myocardial Infarction trials