Out-of-hospital Cardiac ArrestCASCADENCT04993716
Epidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes
An observational study of Out-of-hospital Cardiac Arrest, run by Stephane Sanchez at 1 site in France.
Trial summary
Out-of-hospital cardiac arrest (OHCA) is a public health problem, affecting 50,000 people per year in France. Intervention time (initiation of cardiopulmonary resuscitation (CPR) and advanced CPR) are associated with a better prognosis. Despite this, the latest published data show a very low overall survival (5%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- observational
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2021to 31 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our participants must be the victim of an ACEH on the Champagne-Ardenne territory admitted living in the hospital and be over eighteen years old
Who may be able to join
- Patient victim of ACEH in the Champagne-Ardenne region admitted living in hospital.
Who cannot join
- patient under the age of 18
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
hospital center of Troyes
Troyes, Champagne Ardennes, 10000
Stéphane SANCHEZ
About this study
Out-of-hospital cardiac arrest (OHCA) is a public health problem, affecting 50,000 people per year in France. Intervention time (initiation of cardiopulmonary resuscitation (CPR) and advanced CPR) are associated with a better prognosis. Despite this, the latest published data show a very low overall survival (5%). Our territory has only three centers distributed hospitals with both a 24-hour coronary angiography platform and an intensive care unit. Finally, although 60% of ACEHs receive coronary angiography in the Île de France region, it is performed on only 15% of patients in the Reims University Hospital.
Therefore, it seems essential to conduct a study on the reality of the support of ACEH and to study the clinical and biological factors as well as the influence of the geographical distribution of specialized technical platforms on the prognosis of patients.
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- observational
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
Collect from a bank of biological samples, identification of prognostic factors associated with survival without serious neurological heavy sequelae
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patient present in the SAU after an extra-hospital cardiac arrest Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) at 3 months among the following variables
Measured: 3 months
Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) with collection of a bank of biological samples, identification of clinical factors and targeted temperature control
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start4 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Stephane Sanchez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephane Sanchez, Centre Hospitalier de Troyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993716
- Sponsor's protocol ID
- The CASCADE Study
- Acronym
- CASCADE
- Status last verified
- Jul 2022
- First submitted
- 18 Jun 2021
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes
- ClinicalTrials.gov ID
- NCT04993716
- Acronym / sponsor ID
- CASCADE / The CASCADE Study
- Conditions
- Out-of-hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Stephane SanchezUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Out-of-hospital cardiac arrest (OHCA) is a public health problem, affecting 50,000 people per year in France. Intervention time (initiation of cardiopulmonary resuscitation (CPR) and advanced CPR) are associated with a better prognosis. Despite this, the latest published data show a very low overall survival (5%). Our territory has only three centers distributed hospitals with both a 24-hour coronary angiography platform and an intensive care unit. Finally, although 60% of ACEHs receive coronary angiography in the Île de France region, it is performed on only 15% of patients in the Reims University Hospital.
Therefore, it seems essential to conduct a study on the reality of the support of ACEH and to study the clinical and biological factors as well as the influence of the geographical distribution of specialized technical platforms on the prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: observationalPatient present in the SAU after an extra-hospital cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our participants must be the victim of an ACEH on the Champagne-Ardenne territory admitted living in the hospital and be over eighteen years old
Key inclusion criteria (1 listed)
- Patient victim of ACEH in the Champagne-Ardenne region admitted living in hospital.
Key exclusion criteria (1 listed)
- patient under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalCollect from a bank of biological samples, identification of prognostic factors associated with survival without serious neurological heavy sequelae | Other | Cohort |
Primary outcome
Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) at 3 months among the following variables
Time frame: 3 months
Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) with collection of a bank of biological samples, identification of clinical factors and targeted temperature control
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-of-hospital Cardiac Arrest, run by Stephane Sanchez at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Sanchez, MD (+33625036892, stephane.sanchez@hcs-sante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) at 3 months among the following variables (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.