Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack? (CHIPAHA)

March 9, 2023 updated by: Life Recovery Systems
The hypothesis of this study is that consciously sedated patients suffering from ST-elevation myocardial infarction can be rapidly and safely cooled to a state of therapeutic hypothermia (32 to 34 degrees C) using the LRS ThermoSuit System prior to percutaneous coronary intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study will investigate the safety and feasibility of cooling heart attack (STEMI) patients with the LRS (Life Recovery Systems)ThermoSuit System, a cooling device which uses the principle of cold water immersion to rapidly reduce patient temperature. The study will enroll a total of up to 20 patients, and will be a cooperative effort between LRS and LSU Health Sciences Center - Shreveport.

The study is being conducted under an IDE (Investigational Device Exemption) that was granted to LRS by FDA (G070141). The primary goal of this trial is to demonstrate the feasibility of cooling AMI patients pre-reperfusion with the ThermoSuit cooling device. The safety of this treatment will be determined by review of a composite of serious adverse events.

Consciously sedated patients will be cooled after entry into the emergency room and prior to percutaneous coronary intervention in the catheterization laboratory. It is hypothesized that the ThermoSuit System will enable cooling of the patient to 34ºC after a treatment of 30 minutes or less. Previous research has suggested that cooling of ST-elevation myocardial infarction patients before coronary reperfusion could result in a significant reduction in myocardial infarct size.

If successful, this study will lead to a pivotal clinical study to investigate the potential for the ThermoSuit cooling treatment to reduce myocardial infarct size. The ultimate goal of these studies is to determine the safety and effectiveness of the use of the ThermoSuit device for the treatment of AMI patients.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • UTHSCSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Duration of MI symptoms ≥ 30 minutes to ≤ 6 hours.
  • ST-segment elevation of ≥ 1mm or more in two or more contiguous leads.
  • Eligible for PCI.
  • Willingness of patient or legal guardian to provide written, informed consent.
  • Patient dimension criteria:
  • Height: 147-190 cm (58 - 75 in)
  • Width: ≤73 cm (29 in) (elbow to elbow)

Exclusion Criteria:

  • Cardiac arrest or previous MI within one month.
  • Administration of thrombolytics.
  • Cardiogenic shock (systolic blood pressure (SBP) < 80 mmHg for > 30 minutes or SBP < 100 mmHg on vasopressors or IABP) in the absence of bradycardia or other correctable causes.
  • Known hypersensitivity to hypothermia including Raynaud's disease or cryoglobulinemia.
  • Severe allergy or contraindication to aspirin, Plavix, heparin, or contrast media which cannot be adequately pre-medicated.
  • History of bleeding diathesis or coagulopathy or refusal of blood transfusions.
  • Pregnancy.
  • Known hypersensitivity midazolam, meperidine, buspirone, or magnesium sulfate.
  • Current enrollment in another clinical trial (other than registry).
  • Temperature < 35°C on admission to Emergency Department.
  • Recent (< 1 week) surgical incisions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ThermoSuit-Induced Patient Cooling
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
Device: Life Recovery Systems ThermoSuit
Hypothermia induction (cooling to 32 to 34 degrees C core temperature) using the Life Recovery Systems ThermoSuit System (a device which cools patients using direct skin contact with cold water) followed by PCI (percutaneous coronary intervention) and maintenance of hypothermia for 3 hours following PCI.
Other Names:
  • Life Recovery Systems ThermoSuit(R) System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of use of cooling device as determined by ability and time to achieve target temperature and ease of maintaining temperature in therapeutic range (32 to 34°C) for three hours following removal of patient from ThermoSuit.
Time Frame: Four hours
Four hours
Primary safety endpoint: composite of serious adverse events including: death, re-infarction, ischemia-driven TVR, pneumonia, sepsis, arrhythmia, bleeding, stroke, and renal failure.
Time Frame: 30 days post-hospital discharge
30 days post-hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events at 30 days as defined by death or non-fatal re-infarction. c. Ischemia-driven target vessel revascularization.
Time Frame: 30 days post-hospital discharge
30 days post-hospital discharge
Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging.
Time Frame: 30 days post-hospital discharge
30 days post-hospital discharge
Safety, including all-cause mortality, cardiac, vascular, and hematological complications.
Time Frame: 30 days post-hospital discharge
30 days post-hospital discharge
Adverse events associated with conscious sedation.
Time Frame: 30 days post-hospital discharge
30 days post-hospital discharge
Arterial blood pressure and heart rate every 5 minutes from the baseline just before the start of cooling until 30 minutes after cooling has started.
Time Frame: One hour
One hour
Door to balloon time.
Time Frame: 90 minutes
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life Recovery Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 28, 2024

Primary Completion (Anticipated)

February 28, 2025

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRS-01-07-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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