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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 belowSelect...
I am 18 years old or older.
Select...
My heart attack symptoms lasted between 30 minutes and 6 hours.
Select...
I am eligible for a heart procedure to improve blood flow.
CHIPAHA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four hours
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 moreCHIPAHA 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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known sensitivity to cold temperatures, such as having Raynaud's disease or cryoglobulinemia.You have a history of blood clotting problems or do not want to receive blood transfusions.I have had a heart attack or cardiac arrest in the last month.I am 18 years old or older.I had surgery less than a week ago.Your body temperature is less than 35°C when you arrive at the Emergency Department.I have had very low blood pressure for more than 30 minutes without a slow heartbeat.My heart attack symptoms lasted between 30 minutes and 6 hours.I am eligible for a heart procedure to improve blood flow.I have severe allergies to aspirin, Plavix, heparin, or contrast media that can't be managed with medication.You are allergic to midazolam, meperidine, buspirone, or magnesium sulfate.You have a specific heart condition where the ST segment on an electrocardiogram is elevated by 1mm or more in two or more nearby leads.I have received clot-dissolving medication.
Research Study Groups:
This trial has the following groups:- Group 1: ThermoSuit-Induced Patient Cooling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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