Status:
UNKNOWN
Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
Lead Sponsor:
Life Recovery Systems
Conditions:
ST-Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
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 deg...
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 principl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00763828
Start Date
January 28 2024
End Date
May 31 2025
Last Update
March 10 2023
Active Locations (1)
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1
UTHSCSA
San Antonio, Texas, United States, 78229-3900