Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
NCT ID: NCT00763828
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2024-01-28
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ThermoSuit-Induced Patient Cooling
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Life Recovery Systems
OTHER
Responsible Party
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Principal Investigators
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Robert J Freedman, M.D.
Role: STUDY_CHAIR
Life Recovery Systems
Locations
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UTHSCSA
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LRS-01-07-01
Identifier Type: -
Identifier Source: org_study_id
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