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Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?

NCT00763828 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-10

No results posted yet for this study

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.

Conditions

  • ST-Elevation Myocardial Infarction

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Life Recovery Systems

    lead OTHER

Principal Investigators

  • Robert J Freedman, M.D. · Life Recovery Systems

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-28
Primary Completion
2025-02-28
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00763828 on ClinicalTrials.gov