Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?

Status unconfirmed · Not applicable

Conditions studied: ST-Elevation Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT00763828

Run by

Life Recovery Systems

People needed

20

Starts

2024-01-28

Expected to finish

2025-05-31

Last updated by the study team

2023-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UTHSCSA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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