Long-term follow-up of cardiac arrest survivors treated with ultra-rapid cooling
Official title: Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling, a Prospective Non-interventional Cohort
Run by Assistance Publique - Hôpitaux de Paris · NCT07028372 · Data updated 2026-11-12
This follow-up will see if people who survived cardiac arrest after ultra-rapid cooling with Vent2Cool have better long-term function and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Angers and 1 other locations) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | December 2031 |
| Study ends | December 2031 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07028372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who were included in the OverCool investigation, received the Vent2Cool procedure, and were alive 28 days after cardiac arrest with no opposition to follow-up.
✕Probably not a fit
Patients who were included but did not receive the Vent2Cool procedure, those who refuse follow-up, or those who cannot be reached are not eligible and will not benefit from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational long-term follow-up of adults who were enrolled in the OverCool investigation and received ultra-rapid cooling with the Vent2Cool system, with inclusion limited to those alive 28 days after cardiac arrest. Data collection includes patient-reported outcomes and functional measures such as the SF-36, modified Rankin Score, ADL questionnaire, NYHA class, and SGRQ, obtained with non-opposition/consent within three months after the parent study. The study is conducted at participating French centers (Angers University Hospital and AP-HP Cochin Hospital) and documents morbidity, mortality, and quality-of-life trajectories after post-cardiac arrest syndrome. The aim is to characterize long-term safety, functional recovery, and respiratory and cardiac status following ultra-rapid hypothermia induction by total liquid ventilation.
Why it matters
Potential benefit: If successful, this follow-up could show that ultra-rapid cooling reduces long-term neurological and cardiac complications and improves survivors' quality of life.
How similar studies have gone: External targeted temperature management trials have shown mixed results, while animal studies and limited human data suggest earlier cooling is beneficial; hypothermic total liquid ventilation (Vent2Cool) is a novel approach with limited clinical experience to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 years and over * Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest) * Non-opposition from the patient or the trusted person or the close relative or parent obtained within 3 months after the end of the OverCool study Exclusion Criteria: * Follow-up refusal from patient of trusted person or the close relative or parent * Having being included in the OverCool clinical investigation but not submitted to the Vent2Cool procedure * Impossibility to reach the patient or the trusted person or the close relative or parent
Where it's running
-
AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit
Paris, France Recruiting -
Angers University Hospital, Medical Intensive Care Unit, Vent'Lab
Angers, France Not yet recruiting
Study contacts
- Principal investigator: Alain CARIOU, MD PhD — AP-HP, Cochin Hospital, Intensive Care and Resuscitation Department
- Study coordinator: Alain CARIOU, MD PhD
- Email: alain.cariou@aphp.fr
- Phone: +33 1 58 41 25 01
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.