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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04584463
Other study ID # 2019PI166
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 30, 2020
Est. completion date November 30, 2021

Study information

Verified date October 2020
Source Central Hospital, Nancy, France
Contact BRUNO LEVY, MD-PHD
Phone 03 83 15 40 84
Email b.levy@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.


Description:

Pre-hospital factors associated with poor neurologic outcome are well known. Meanwhile, in-ICU factors for the first 24 hours may impact neurologic outcome.

This observational study aim to study the factors such as ECLS, NSE dosage, therapeutic hypotermia... and their association with neurologic outcome in patient with myocardial infarction due to instable coronaropathy complicated by an out-of-+hospital cardiac arrest.

This is designed to be a observationnal, prospective, multicentric national french study


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date November 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- aged of 18 years old or more

- non opposition of the patient, or his family if he is unable to consent, after loyal and comprehensive explanation

- patient admitted in ICU

- the reason for admission is a resurected out-of-hospital cardiac arrest

- the cause of the cardiac arrest is a type 1 myocardial infarction

Exclusion Criteria:

- refractory cardiac arrest (no flow > 30 minutes in normothermia)

- in-hospital cardiac arrest

- pregnancy

- patient under juridic protection

- opposition of the patient, or of his family is he is unable to consent.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary Neurologic outcome (CPC) Cerebral Performance Category Scale to assess neurologic outcome 1-2 : good outcome 3-4-5 : bad outcome 30 day from in-ICU admission
Secondary Neurologic outcome (Rankin) Rankin score to assess neurologic outcome
0-1-2 good outcome
3-4-5 bad outcome
30 day from in-ICU admission
Secondary death all-causes death 30 day form in-ICU admission
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