HYPOTHERMIA INDUCED VIA AUTOMATED PERITONEAL LAVAGE FOLLOWING CARDIAC ARREST OR ACUTE ST-ELEVATION MYOCARDIAL INFARCTIO

Recruiting

• Conditions: cardiac arrest; 10011082; 10014623

• Registration Number: NL-OMON36573
• Lead Sponsor: Velomedix, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. cardiac arrest (in-hosptial or out-of hospital) with return of spontaneous circulation
2. myocardial infarction (18-85 years): STEMI

Exclusion Criteria

1. Subject is known to be pregnant;
2. Subject is obeying commands;
3. Subject has a known history of abdominal surgery, peritonitis, or
currently undergoing regular peritoneal dialysis;
4. Subject has a known history of severe chronic obstructive
pulmonary disorder (COPD) (i.e., requires supplemental home
oxygen);
5. Subject has a known anatomic abnormality that in the
physician*s opinion will create additional risk when treating the
patient (i.e., profound obesity, abdominal aortic aneurysm,
abdominal wall hernia, spinal deformity, etc.);
6. Subject has a known severe neurological dysfunction evident
prior to the presenting acute event;
7. Subject has known significant concomitant illness (other than
cardiac arrest) with a life expectancy of < 1 year;
8. Subject is experiencing active, uncontrolled bleeding;
9. Subject has a known history of receiving thrombolytic
medication in the previous 6 weeks (treatment with other
anticoagulant medications, such as those required for PCI or
STEMI treatment, is not an exclusion);
10. cardiac arrest caused by massive CVA or trauma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety (composite of new-onset serious adverse event(s), feasibility, side<br /><br>effects, and efficacy (infarct size).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* CA subgroup (with or without STEMI): Percentage of subjects with good<br /><br>neurologic outcome (Glasgow<br /><br>Outcome Score of 4 or 5] at any time during their hospital stay) and at 6 months<br /><br><br /><br>* STEMI subgroup (with or without CA): Myocardial infarct size at 14 days (± 3<br /><br>days) post-procedure as measured by Tc99m Sestamibi single photon emission<br /><br>computed tomography (SPECT).<br /><br><br /><br>* All cause mortality through 6 months post-procedure.<br /><br><br /><br>* Device success defined as the capability of the device to decrease subject<br /><br>core temperature to 34°C within 30 minutes of treatment.<br /><br><br /><br>* STEMI subgroup (without CA): MACE at 30 days (± 7 days) as defined by death<br /><br>or non-fatal reinfarction or ischemia-driven TVR.</p><br>