Hypothermia Treatment for Heart Attack

(CHIPAHA Trial)

Overseen By Rick Hettenbach, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Life Recovery Systems

Must not be taking: Thrombolytics, Midazolam, Meperidine, others

Disqualifiers: Cardiac arrest, Pregnancy, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have severe allergies or contraindications to certain drugs like aspirin, Plavix, or heparin, you may not be eligible to participate.

What data supports the effectiveness of the hypothermia treatment for heart attack?

Research shows that therapeutic hypothermia, which involves cooling the body, can improve survival and brain function after cardiac arrest. Studies have demonstrated that mild hypothermia reduces neurological damage and mortality in patients who have been resuscitated from cardiac arrest, making it a recommended treatment in post-resuscitation care. ^{1 2 3 4 5}

Is hypothermia treatment generally safe for humans?

Therapeutic hypothermia (cooling the body to lower temperatures) is considered a safe treatment when used properly, as long as potential issues are managed. It has been shown to be safe and effective in various conditions, including cardiac arrest and cardiogenic shock (a condition where the heart suddenly can't pump enough blood). ^{6 7 8 9 10}

How does the ThermoSuit treatment for heart attack differ from other treatments?

The ThermoSuit treatment is unique because it rapidly cools the body by pumping ice water over the skin, which can improve neurological outcomes after a heart attack. This method of inducing mild hypothermia is different from other treatments that may not focus on rapid surface cooling. ^{1 9 10 11 12}

Research Team

Robert J Freedman, M.D.

Principal Investigator

Life Recovery Systems

Eligibility Criteria

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.

Inclusion Criteria

Willingness of patient or legal guardian to provide written, informed consent

I am 18 years old or older.

Patient dimension criteria: Height: 147-190 cm (58 - 75 in), Width: ≤73 cm (29 in) (elbow to elbow)

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Cooling Treatment

Consciously sedated patients are cooled to a state of therapeutic hypothermia using the ThermoSuit System prior to percutaneous coronary intervention

30 minutes

1 visit (in-person)

Percutaneous Coronary Intervention

Patients undergo percutaneous coronary intervention in the catheterization laboratory after cooling

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Life Recovery Systems ThermoSuit

Trial Overview 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.

Participant Groups

Group I: ThermoSuit-Induced Patient Cooling Experimental Treatment 1 Intervention

The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.

Who Is Running the Clinical Trial?

Life Recovery Systems

Lead Sponsor

Trials

5

Recruited

70+

Findings from Research

The Arctic Sun Temperature Management System effectively induced therapeutic hypothermia in cardiac arrest survivors, achieving the target temperature of 32-34 °C within an average of 2.78 hours for 80% of patients.

While minor skin injuries occurred in 20% of patients, these were primarily linked to shock and low left ventricular ejection fraction, indicating that careful monitoring is needed for at-risk patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface cooling after cardiac arrest: effectiveness, skin safety, and adverse events in routine clinical practice. Jarrah, S., Dziodzio, J., Lord, C., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiopulmonary bypass resuscitation for accidental hypothermia. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Hospital-based use of therapeutic hypothermia after cardiac arrest in adults. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia: implications for acute care practitioners. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hypothermia improves outcome from cardiac arrest. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Contemporary practices in postcardiac arrest syndrome: the role of mild therapeutic hypothermia. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Surface cooling after cardiac arrest: effectiveness, skin safety, and adverse events in routine clinical practice. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

[Therapeutic hypothermia: effects beyond neuroprotection]. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Portable cardiopulmonary bypass: resuscitation from prolonged ice-water submersion and asystole. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of hypothermia by extracorporeal circulation and internal rewarming. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia with a novel surface cooling device improves neurologic outcome after prolonged cardiac arrest in swine. [2008]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[To what extent is cardiac work capacity preserved after long periods of clinical death under hypothermia?]. [2016]

12. Canada pubmed.ncbi.nlm.nih.gov

Cardiopulmonary bypass for resuscitation of patients with accidental hypothermia and cardiac arrest. [2007]