Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack? (CHIPAHA)
Primary Purpose
ST-Elevation Myocardial Infarction
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Recovery Systems ThermoSuit
Sponsored by
About this trial
This is an interventional treatment trial for ST-Elevation Myocardial Infarction focused on measuring Myocardial Infarction, Hypothermia, Induced
Eligibility 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.
Sites / Locations
- UTHSCSA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ThermoSuit-Induced Patient Cooling
Arm Description
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
Outcomes
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.
Primary safety endpoint: composite of serious adverse events including: death, re-infarction, ischemia-driven TVR, pneumonia, sepsis, arrhythmia, bleeding, stroke, and renal failure.
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.
Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging.
Safety, including all-cause mortality, cardiac, vascular, and hematological complications.
Adverse events associated with conscious sedation.
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.
Door to balloon time.
Full Information
NCT ID
NCT00763828
First Posted
September 30, 2008
Last Updated
March 9, 2023
Sponsor
Life Recovery Systems
1. Study Identification
Unique Protocol Identification Number
NCT00763828
Brief Title
Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
Acronym
CHIPAHA
Official Title
Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 28, 2024 (Anticipated)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Recovery Systems
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-Elevation Myocardial Infarction
Keywords
Myocardial Infarction, Hypothermia, Induced
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ThermoSuit-Induced Patient Cooling
Arm Type
Experimental
Arm Description
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
Intervention Type
Device
Intervention Name(s)
Life Recovery Systems ThermoSuit
Other Intervention Name(s)
Life Recovery Systems ThermoSuit(R) System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging.
Time Frame
30 days post-hospital discharge
Title
Safety, including all-cause mortality, cardiac, vascular, and hematological complications.
Time Frame
30 days post-hospital discharge
Title
Adverse events associated with conscious sedation.
Time Frame
30 days post-hospital discharge
Title
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
Title
Door to balloon time.
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert B Schock, Ph.D.
Phone
973-283-2800
Email
bschock@life-recovery.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rick Hettenbach, MA
Phone
973-283-2800
Email
rhettenbach@life-recovery.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Freedman, M.D.
Organizational Affiliation
Life Recovery Systems
Official's Role
Study Chair
Facility Information:
Facility Name
UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven R Bailey, MD
Phone
210-567-3885
Email
BailyS@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Joan Drake, RN, BSN, MPH
Phone
210-567-8692
Email
DrakeP@uthscsa.edu
12. IPD Sharing Statement
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