Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
CHIPAHA
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 1, 2008
CompletedStudy Start
First participant enrolled
January 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 10, 2023
March 1, 2023
1.1 years
September 30, 2008
March 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
30 days post-hospital discharge
Secondary Outcomes (6)
Major adverse cardiac events at 30 days as defined by death or non-fatal re-infarction. c. Ischemia-driven target vessel revascularization.
30 days post-hospital discharge
Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging.
30 days post-hospital discharge
Safety, including all-cause mortality, cardiac, vascular, and hematological complications.
30 days post-hospital discharge
Adverse events associated with conscious sedation.
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.
One hour
- +1 more secondary outcomes
Study Arms (1)
ThermoSuit-Induced Patient Cooling
EXPERIMENTALThe Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UTHSCSA
San Antonio, Texas, 78229-3900, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert J Freedman, M.D.
Life Recovery Systems
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 1, 2008
Study Start
January 28, 2024
Primary Completion
February 28, 2025
Study Completion
May 31, 2025
Last Updated
March 10, 2023
Record last verified: 2023-03