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 range

18 Years

Sex

ALL

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was withdrawn before enrolling patients — are there other active trials studying cooling therapy before or during a heart attack procedure that I might be a candidate for?
2Since this study was trying to cool the body to 34°C or below during a stent procedure, what does my doctor think about the current evidence for cooling as a way to protect heart muscle during a heart attack, and is it used in standard care anywhere?
3The trial was measuring serious cardiac events at 30 days after the procedure — how does my own risk of complications in the 30 days following a PCI compare to what's typical, and should that affect which treatment path we consider?
4Since this was labeled as a pilot or early-phase safety study, does that mean the overall concept of cooling during PCI is still experimental, and what would my doctor recommend instead while this research is still developing?
5Are there any completed trials on cooling therapy during heart attacks whose results my doctor could share with me, so we can discuss whether this approach might eventually become part of my care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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