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Not yet recruiting NCT07468292

GARDE : GC7 (N1-guanyl-1,7 Diaminoheptane) cARDiac arrEst

No phase Interventional Cardiac Arrest (CA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GC7 exposure, No GC7 exposure.
Who it may be relevant to
Registry conditions: Cardiac Arrest (CA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of GC7 (N1-guanyl-1,7 Diaminoheptane) on Oxidative Stress in Patients Who Have Experienced a Resuscitated Cardiorespiratory Arrest

Overview

Cardiac arrest (CA) with return of spontaneous circulation is associated with high mortality, exceeding 90% in out-of-hospital settings and approaching 50% in in-hospital settings. Despite management of the underlying cause of CA, patients often die from post-anoxic brain injury or from ischemia-reperfusion injury occurring after reperfusion and reoxygenation, which increases oxidative stress and leads to multi-organ failure. To date, no effective therapeutic strategy has been established in humans to limit these ischemia-reperfusion injuries. GC7 (N1-guanyl-1,7 diaminoheptane) has demonstrated a strong protective potential against ischemia reperfusion injury in rodent and porcine models, including myocardial infarction, stroke, and renal transplantation. These protective effects are attributed to the pleiotropic action of GC7 which renders cells and tissues energetically less dependent on oxygen, and reduces oxidative stress which play a major role in ischemia reperfusion injury. Degree of blood acidification and immune dysregulation may also represent parameters that GC7 could potentially influence. Although no adverse effects have been reported in these experimental models, GC7 has not yet been studied in human. Our study therefore aims to demonstrate the protective effect of GC7 on blood cells in patients after CA by evaluating oxidative stress levels, blood acidification and inflammatory profile.

Interventions

  • Other GC7 exposure
    24-hour exposure of patient 's blood to GC7 molecule
  • Other No GC7 exposure
    No exposure of blood to GC7 molecule

Primary outcome measures

  • Blood oxidative stress levels [Time frame: at 24 hours after blood exposure to GC7]
Secondary outcome measures (2)
  • Blood acidification [Time frame: 24 hours after blood exposure to GC7]
  • Blood inflammatory profile [Time frame: 24 hours after blood exposure to GC7]

Eligibility criteria

Inclusion criteria

  • Cardiac arrest as the primary reason for hospital admission
  • Admission < 48 hours
  • Age ≥ 18 years
  • Affiliated with a social security system

Exclusion criteria

  • Limitation or withdrawal of life-sustaining therapies prior to study screening
  • Prior cardio-vascular ischemic event (> 24h) before cardiac arrest
  • Patient deprived of liberty

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU de Nice - Hôpital PASTEUR 2 — Nice

Identifiers

NCT: NCT07468292 · 25-AOIP-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗