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Acute Myocardial InfarctionSTEMI CoolNCT03361995

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

A study testing Cooling Procedure using the ZOLL Thermogard XP3 IVTM System and PCI in people with Acute Myocardial Infarction, run by ZOLL Circulation, Inc., USA.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Cooling Procedure using the ZOLL Thermogard XP3 IVTM System and PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
20 Feb 2020to 12 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Patient has a known history of untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Meperidine administration.
  • The patient has an Inferior Vena Cava filter in place (IVC).
  • The patient has an anticipated life expectancy of <1 year.
  • The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
  • The patient is currently enrolled in another investigational drug or device trial.
  • The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has a Gadolinium allergy.
  • The patient has received thrombolytic therapy en route to the hospital.
  • The patient has received any oral P2Y12 inhibitors prior to enrollment.
  • The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/or from ECG findings (partial or complete ST resolution in ECG prior to informed consent and randomization).
  • The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state).
  • The patient is a female who is known to be pregnant or expected to become pregnant.
  • In the opinion of Investigator or designee the patient is not willing and able to comply with all the study requirements.

About this study

Official title: STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients With Acute Myocardial Infarction (Phase A)

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.

Read the detailed description

The overall objective of this randomized trial is to evaluate the Safety and Efficacy of intravascular cooling using the ZOLL Thermogard XP3 IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction and undergoing PCI.

The objective of the Phase A trial is to demonstrate successful incorporation of intravascular cooling into US standard of care.

Being tested
Cooling Procedure using the ZOLL Thermogard XP3 IVTM System, PCI
Keywords
STEMI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cooling Procedure using the ZOLL Thermogard XP3 IVTM SystemDevice

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

  • PCIDevice

    Standard of Care for PCI

Study groups in NCT03361995
Study groupRoleWhat they receive
Cooling + PCIExperimentalThe 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.
Receives: Device: Cooling Procedure using the ZOLL Thermogard XP3 IVTM System; Device: PCI
PCI onlyActive comparatorThe 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.
Receives: Device: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, approximately 1 year

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

    Measured: Through study completion, approximately 1 year

Secondary outcomes (2)

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

    The performance goal is at least 93.5% of the patients in Phase A, with Test and Control arms evaluated separately.

    Measured: Through study completion, approximately 1 year

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

    Rate of a composite safety endpoint at 30 days defined as the following:

    • Cardiovascular death
    • 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

    Measured: Through study completion, approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study start20 Feb 2020
  3. Primary completion12 May 2022
  4. Study completion12 May 2022

Why it stopped: due to COVID repercussions

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361995
Sponsor's protocol ID
EDC-2309 Rev 15
Acronym
STEMI Cool
Status last verified
Oct 2020
First submitted
8 Nov 2017
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: The study is registered on ClinicalTrials.gov to make information about the trial publicly available. At all times, including early termination of the study, the sponsors will comply with the reporting requirements of applicable clinical trials registered on ClinicalTrials.gov under the FDA Amendments Act (FDAAA).

Questions about this trial

What is this clinical trial studying?

A study testing Cooling Procedure using the ZOLL Thermogard XP3 IVTM System and PCI in people with Acute Myocardial Infarction, run by ZOLL Circulation, Inc., USA.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase A Safety Endpoint: Incidence of MACE at 30 days. (time frame: Through study completion, approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03361995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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