Study Stopped
Lack of study funding
Prehospital Resuscitation Intranasal Cooling Effects Seen in MRI of the Brain After Cardiac Arrest
COOLCAMRI
Sponsor study identifier
observational
12
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 1, 2016
Actual (reported)Study Completion
April 1, 2016
Actual (reported)Therapeutic hypothermia improves the neurologically-intact survival rates in those patients resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted magnetic resonance imaging have recently shown to be able to identify early ischemia-related changes within the brain three days after cardiac arrest, among sudden cardiac arrest patients cooled in hospital. The physical changes seen within the brain may be able to distinguish survivors at very early phase. This study aims to assess early ischemia-related changes of the brain seen in MRI approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the groups of patients treated with early intra-arrest cooling with the RhinoChill device and in hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33 Celsius).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 2, 2014
Actual (reported)July 1, 2014
Actual (reported)April 1, 2016
Actual (reported)April 1, 2016
Actual (reported)the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI
36-49 hours after cardiac arrest
the total survival at 90 days
90 days after cardiac arrest
time to reach a target temperature (≤36/33 Celsius)
0-12hours after cardiac arrest
The RhinoChill® cooling is started as soon as possible to the patients with Cardiac arrest, and before the return of spontaneous circulation
Standard care, no cooling during pre-hospital care
The subjects will be derived from the prehospital cardiac arrest patients from Tampere area treated by the Tampere Area Emergency Medical Service (EMS) led by physician. The study population (N=10) is from Pirkanmaa area. The paramedics are allowed to start intra-arrest cooling by RhinoChill whenever they meet an adult SCA patient in VF/VT. The third group of control subjects are same as used in "Effect of Xenon, in Combination with Therapeutic Hypothermia, on the Brain and on Neurological Outcome following Brain Ischemia in Cardiac Arrest Patients (EudraCT number 2009-009505-25)" -study running in Turku and Helsinki, Finland. They are the prehospital cardiac arrest patients from Turku and Helsinki area treated by the Turku or Helsinki Area Emergency Medical Service.
Tampere University hospital
Tampere, 33521, Finland
Sanna Hoppu, MD, PhD
12 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2014
First Posted
July 1, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Seizure Detection Using SEDline During Therapeutic Hypothermia in Cardiac Arrest Victims
Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland
Contact the study team to confirm eligibility.
Primary Completion
April 1, 2016
Actual (reported)Study Completion
April 1, 2016
Actual (reported)Last Updated
March 21, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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