Prognostic Value of Cardiac and Renal Markers in Ischemic Stroke and Transient Ischemic Attack - Full Text View

Sponsored by:	University Hospital, Tours
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00479518

Purpose

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.

Condition
Ischemic Stroke Transient Ischemic Attack

MedlinePlus related topics: Transient Ischemic Attack

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prognostic Value of Cardiac and Renal Markers in the Acute Phase of Ischemic Stroke or Transient Ischemic Attack :Albuminuria-Brain Natriuretic Peptide-Cystatine C in Stroke

Further study details as provided by University Hospital, Tours:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood Urine

Estimated Enrollment:	300
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2012

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient with Ischemic stroke or TIA

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479518

Contacts

Contact: BONNAUD Isabelle, MD	(33) 2 47 47 16 07	i.bonnaud@chu-tours.fr
Contact: RAMEAU Pascaline, CRA	(33) 2 47 36 62 49	rameau@med.univ-tours.fr

Locations

France
Service de Neurologie / CHRU de Tours	Recruiting
TOURS, France, 37044
Contact: BONNAUD Isabelle, MD (33) 2 47 47 16 07 i.bonnaud@chu-tours.fr
Contact: RAMEAU Pascaline, CRA (33) 2 47 36 62 49 rameau@med.univ-tours.fr
Sub-Investigator: AUTRET Alain, PHD
Sub-Investigator: DEBIAIS Séverine, MD
Sub-Investigator: SAUDEAU Denis, MD
Sub-Investigator: HALIMI Jean-Michel, PHD
Service de neurologie / CHU Pontchaillou	Not yet recruiting
RENNES, France, 35033
Contact: RONZIERE Thomas, MD
Sub-Investigator: RONZIERE Thomas, MD
Sub-Investigator: PINEL Jean-François, MD
Sub-Investigator: CAHAGNE Vincent, MD
Service de Neurologie / Hopital LAENNEC	Recruiting
Nantes, France, 44093
Contact: GUILLON Benoît, MD
Sub-Investigator: MAGNE Christine, MD
Sub-Investigator: GUILLON Benoît, MD
Sub-Investigator: LAPLAUD David, MD
Sub-Investigator: WIERTLEWSKI Sandrine, MD

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:

BONNAUD Isabelle, MD

Service de Neurologie / CHRU de Tours

More Information

No publications provided

Responsible Party:	University Hospital Tours ( University Hospital Tours / Jocelyne Marlière )
Study ID Numbers:	PHRI06-IB Cohorte ABC-AVC
Study First Received:	May 25, 2007
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00479518 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Tours:

stroke
transient ischemic attack
albuminuria
BNP
Cystatin C

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Ischemic Attack, Transient
Albuminuria
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases

Ischemia
Brain Diseases
Cerebrovascular Disorders
Brain Ischemia
Brain Infarction
Cystatins
Infarction

Additional relevant MeSH terms:

Ischemic Attack, Transient
Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Ischemia

Brain Diseases
Cerebrovascular Disorders
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on May 07, 2009