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

This study is not yet open for participant recruitment.
Verified January 2014 by Life Recovery Systems
Sponsor:
Information provided by (Responsible Party):
Life Recovery Systems
ClinicalTrials.gov Identifier:
NCT00763828
First received: September 30, 2008
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
ST-Elevation Myocardial Infarction
Device: Life Recovery Systems ThermoSuit
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?

Resource links provided by NLM:


Further study details as provided by Life Recovery Systems:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging. [ Time Frame: 30 days post-hospital discharge ] [ Designated as safety issue: Yes ]
  • Safety, including all-cause mortality, cardiac, vascular, and hematological complications. [ Time Frame: 30 days post-hospital discharge ] [ Designated as safety issue: Yes ]
  • Adverse events associated with conscious sedation. [ Time Frame: 30 days post-hospital discharge ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Door to balloon time. [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Life Recovery Systems ThermoSuit(R) System

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763828

Contacts
Contact: Robert B Schock, Ph.D. 973-283-2800 bschock@life-recovery.com
Contact: Rick Hettenbach, MA 973-283-2800 rhettenbach@life-recovery.com

Locations
United States, Louisiana
LSU Health Sciences Center - Shreveport Not yet recruiting
Shreveport, Louisiana, United States, 71103
Contact: Thomas C. Arnold, M.D.    318-675-6885    TARNOL@LSUHSC.EDU   
Sponsors and Collaborators
Life Recovery Systems
Investigators
Principal Investigator: Thomas C. Arnold, M.D. LSU Health Sciences Center - Shreveport
  More Information

No publications provided

Responsible Party: Life Recovery Systems
ClinicalTrials.gov Identifier: NCT00763828     History of Changes
Other Study ID Numbers: LRS-01-07-01
Study First Received: September 30, 2008
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Life Recovery Systems:
Myocardial Infarction
Hypothermia, Induced

Additional relevant MeSH terms:
Hypothermia
Infarction
Myocardial Infarction
Body Temperature Changes
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014