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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
Duration of MI symptoms ≥ 30 minutes to ≤ 6 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes
Awards & highlights

CHIPAHA Trial 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.Check my eligibility
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.See study design
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.

CHIPAHA Trial 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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My heart attack symptoms lasted between 30 minutes and 6 hours.
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I am eligible for a heart procedure to improve blood flow.

CHIPAHA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and four hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thermography
Primary safety endpoint: composite of serious adverse events including: death, re-infarction, ischemia-driven TVR, pneumonia, sepsis, arrhythmia, bleeding, stroke, and renal failure.
Secondary outcome measures
Adverse events associated with conscious sedation.
Arterial blood pressure and heart rate every 5 minutes from the baseline just before the start of cooling until 30 minutes after cooling has started.
Door to balloon time.
+3 more

CHIPAHA 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants in this research?

"According to the clinicaltrials.gov database, this experiment is not currently recruiting any trial participants. Initially posted on January 28th 2023 and last updated on April 4th 2022, there are 410 other studies that are actively searching for candidates right now."

Answered by AI
~13 spots leftby Feb 2025