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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00479518
Other study ID # PHRI06-IB Cohorte ABC-AVC
Secondary ID
Status Completed
Phase N/A
First received May 25, 2007
Last updated February 23, 2017
Start date March 2007
Est. completion date February 2017

Study information

Verified date February 2017
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome, recurrence of cardiovascular events or vascular death.Until now, no reliable predictive biological marker could be identified in the acute phase of stroke.We hypothese that, in the acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide, BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular events or vascular death. We want to assess which one of these markers has the best prognosis value , in a prospective study of 300 stroke patients followed during 3 years.


Description:

Patients with ischemic stroke or TIA will be included in the 48 hours following the onset of symptoms, in 3 university hospitals.For each patient will be collected

- 1 blood sample for the BNP measure in pg/ml

- 1 blood sample for the Cystatin C measure in mg/l

- 2 urinary samples to measure the albumine/creatinine ratio, at inclusion and 5 days after the inclusion, and to study the variation of albuminuria in micrograms/min.

The clinical follow-up will be organized during 3 years. The following events will be notified: poor outcome (defined with the Barthel and Rankin scores), recurrence of cardiovascular or cerebrovascular events, vascular death.

After adjustment on the main clinical prognosis factors, we want to determine wich one of these markers has the best prognosis significance and allows to identify in the acute phase the "high-risk" patients, in order to intensify individual treatment and secondary prevention.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date February 2017
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ischemic stroke or TIA in the first 48 hours following the onset of symptoms

Exclusion Criteria:

- Patient unable to give an informed consent

- Urinary sample impossible to collect

Study Design


Locations

Country Name City State
France Service de Neurologie / Hopital LAENNEC Nantes
France Service de neurologie / CHU Pontchaillou Rennes
France Service de Neurologie / CHRU de Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

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