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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cooling treatment for individuals experiencing a specific type of heart attack called ST-elevation myocardial infarction (STEMI). The researchers aim to determine if quickly and safely lowering the body's temperature can benefit patients before they undergo a procedure to open blocked heart arteries. The treatment uses the Life Recovery Systems ThermoSuit to cool the body to a therapeutic temperature. Suitable candidates for this trial have experienced heart attack symptoms for at least 30 minutes but no more than 6 hours and are scheduled for a procedure to treat blocked arteries. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emergency heart attack care.

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 prior data suggests that the Life Recovery Systems ThermoSuit is safe for inducing therapeutic hypothermia in heart attack patients?

Research has shown that the Life Recovery Systems ThermoSuit is safe for patients. In a study with 24 participants, this cooling system was well-tolerated. The ThermoSuit cools patients quickly by surrounding them with cold water, which might sound intense but remains manageable. This study reported no major safety issues.

Another study supports the safety of using the ThermoSuit for rapid cooling. It demonstrated that cooling patients before treatments like angioplasty (a procedure to open blocked heart arteries) is safe. Although one trial did not achieve its main goal of reducing heart damage, the cooling process itself did not harm the patients.

Overall, studies indicate that the ThermoSuit is safe for cooling patients who have heart attacks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for heart attacks, like drugs that dissolve blood clots or procedures to open blocked arteries, focus on restoring blood flow to the heart. But the ThermoSuit system works differently by cooling the body. This cooling technique, known as therapeutic hypothermia, aims to reduce damage to the heart muscle during a heart attack. Researchers are excited because this method could potentially protect heart tissue more effectively, improving outcomes for patients.

What evidence suggests that the ThermoSuit System is effective for heart attack treatment?

Research has shown that cooling the body to a lower temperature might help reduce heart damage after a heart attack. In this trial, the Life Recovery Systems ThermoSuit System will cool patients using a special method to quickly lower body temperature. In studies with 24 patients, the ThermoSuit System cooled patients effectively and safely without major problems. Early results from these studies suggest that cooling before heart attack treatment might lessen heart damage. These findings indicate that the ThermoSuit System could be effective in treating heart attacks by cooling patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Robert J Freedman, M.D.

Principal Investigator

Life Recovery Systems

Are You a Good Fit for This Trial?

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

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

My heart attack symptoms lasted between 30 minutes and 6 hours.

Exclusion Criteria

I have had a heart attack or cardiac arrest in the last month.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. biospace.com biospace.com/life-recovery-systems-study-of-heart-attack-with-thermosuit-r-system

Life Recovery Systems Study of Heart Attack With ... The goal of this pilot study is to confirm the feasibility and efficacy of external thin film liquid cooling to achieve "target" temperature ...

2. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/1074248414535664

Rapid Induction of Hypothermia by the ThermoSuit System ... This study tests the effectiveness of a novel cooling apparatus on myocardial infarct size and no-reflow area in 2 models of coronary artery occlusion (CAO).

3. life-recovery.com life-recovery.com/pdf/WhitePaper-SafetyofRapidCooling(PN53115%20VerB).pdf

Evidence Supporting the Safety of Rapid Patient Cooling A study of 24 patients treated with the Life Recovery Systems ThermoSuit System, a product which cools with convective ice water immersion, reported patient ...

4. meddeviceonline.com meddeviceonline.com/doc/life-recovery-systems-studies-heart-attack-wi-0001

Life Recovery Systems Studies Heart Attack With ... Previous clinical data suggested early and rapid cooling before reperfusion therapy with primary angioplasty may potentially reduce infarct size ...

5. dicardiology.com dicardiology.com/article/hypothermia-may-extend-door-balloon-time

Hypothermia May Extend Door-to-Balloon Time | DAIC The CHIPAHA Trial is slated to begin to test the efficacy of Life Recovery Systems' ThermoSuit System to cool STEMI patients prior to primary ...