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Hypothermia Device

Hypothermia Treatment for Heart Attack (CHIPAHA Trial)

N/A
Waitlist Available
Research Sponsored by Life Recovery Systems
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Eligible for PCI
Must not have
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
Severe allergy or contraindication to aspirin, Plavix, heparin, or contrast media which cannot be adequately pre-medicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests whether it's safe to use a cooling system to sedated heart attack patients before surgery.

Who is the study for?
This trial is for adults over 18 who've had heart attack symptoms for 30 minutes to 6 hours and show certain signs on a heart test. They must fit specific size criteria, agree to the study's terms, and be eligible for a procedure to open blocked arteries. People with recent cardiac arrests or heart attacks, low blood pressure shock states, allergies to cold temperatures or certain drugs, pregnancy, participation in other trials, recent surgeries or bleeding disorders can't join.
What is being tested?
The study tests if patients having a severe type of heart attack can be quickly cooled down using the ThermoSuit System before getting an artery-opening procedure. The goal is to see if this cooling (therapeutic hypothermia) is safe and effective when done right before fixing the blocked arteries.
What are the potential side effects?
Potential side effects may include reactions related to being cooled rapidly such as shivering or discomfort from the cold. There might also be risks associated with sedation needed during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am eligible for a heart procedure to improve blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had very low blood pressure for more than 30 minutes without a slow heartbeat.
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I have severe allergies to aspirin, Plavix, heparin, or contrast media that can't be managed with medication.
Select...
I have received clot-dissolving medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ThermoSuit-Induced Patient CoolingExperimental Treatment1 Intervention
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.

Find a Location

Who is running the clinical trial?

Life Recovery SystemsLead Sponsor
4 Previous Clinical Trials
51 Total Patients Enrolled
Robert J Freedman, M.D.Study ChairLife Recovery Systems

Media Library

Life Recovery Systems ThermoSuit (Hypothermia Device) Clinical Trial Eligibility Overview. Trial Name: NCT00763828 — N/A
Heart Attack Research Study Groups: ThermoSuit-Induced Patient Cooling
Heart Attack Clinical Trial 2023: Life Recovery Systems ThermoSuit Highlights & Side Effects. Trial Name: NCT00763828 — N/A
Life Recovery Systems ThermoSuit (Hypothermia Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00763828 — N/A
~3 spots leftby Feb 2025
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