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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763828
Recruitment Status : Not yet recruiting
First Posted : October 1, 2008
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Life Recovery Systems

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date September 1, 2020
Estimated Study Start Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • 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 ]
  • Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging. [ Time Frame: 30 days post-hospital discharge ]
  • Safety, including all-cause mortality, cardiac, vascular, and hematological complications. [ Time Frame: 30 days post-hospital discharge ]
  • Adverse events associated with conscious sedation. [ Time Frame: 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 ]
  • Door to balloon time. [ Time Frame: 90 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
Official Title  ICMJE Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ST-Elevation Myocardial Infarction
Intervention  ICMJE 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 Name: Life Recovery Systems ThermoSuit(R) System
Study Arms  ICMJE Experimental: ThermoSuit-Induced Patient Cooling
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
Intervention: Device: Life Recovery Systems ThermoSuit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert B Schock, Ph.D. 973-283-2800 bschock@life-recovery.com
Contact: Rick Hettenbach, MA 973-283-2800 rhettenbach@life-recovery.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763828
Other Study ID Numbers  ICMJE LRS-01-07-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Life Recovery Systems
Study Sponsor  ICMJE Life Recovery Systems
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert J Freedman, M.D. Life Recovery Systems
PRS Account Life Recovery Systems
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP