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

NCT03361995 | Withdrawn DMC FDA Device

• 1 other identifier: EDC-2309 Rev 15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

STEMI

Outcome Measures

Primary Outcomes (2)

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

  MACE is defined as Subjects who experienced any of the following events: * All-cause death (cardiac, vascular, non-cardiovascular) * Myocardial infarction (MI) * Clinically-indicated target vessel revascularization (CI TVR) * Definite or probable stent thrombosis (ST) * New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF * Stroke * Major bleeding

  Through study completion, approximately 1 year

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

  Through study completion, approximately 1 year

Secondary Outcomes (2)

• Phase A Secondary Safety Endpoint 1: Proportion of patients reaching <90 min door-to-balloon time.

  Through study completion, approximately 1 year

• Phase A Secondary Safety Endpoint 2: Rate of a composite safety endpoint at 30 days.

  Through study completion, approximately 1 year

Study Arms (2)

Cooling + PCI

EXPERIMENTAL

The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after PCI.

Device: Cooling Procedure using the ZOLL Thermogard XP3 IVTM System; Device: PCI

PCI only

ACTIVE COMPARATOR

The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.

Device: PCI

Interventions

Cooling Procedure using the ZOLL Thermogard XP3 IVTM System DEVICE

Cooling Procedure with ZOLL Thermogard XP3 IVTM System before and after Percutaneous Coronary Intervention (PCI)

Cooling + PCI

PCI DEVICE

Standard of Care for PCI

Cooling + PCI; PCI only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cardio-pulmonary decompensation that has occurred en route to the hospital or, in the opinion of the physician, that is imminent or likely to occur following presentation to the clinical site.
• Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans).
• Any contraindication to cardiac Magnetic Resonance Imaging (MRI), or any implant in the upper body which may cause artifacts on cardiac MRI imaging.
• The patient has a known hypersensitivity or contraindication to aspirin, heparin, or anaphylaxis to contrast media, which cannot be adequately pre-medicated.
• The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia or sickle cell anemia, or will refuse blood transfusions.
• The patient has a height of \<1.5 meters (4 feet 11 inches).
• The patient has a known hypersensitivity or contraindication to Buspirone hydrochloride or Meperidine and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 5, 2017
• Study Start: February 20, 2020
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: April 15, 2026

Record last verified: 2020-10