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Prognostic Value of Cardiac and Renal Markers in Ischemic Stroke and Transient Ischemic Attack (ABC-AVC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00479518
First received: May 25, 2007
Last updated: April 9, 2009
Last verified: April 2009
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Tours:

Biospecimen Retention:   Samples Without DNA

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

Keywords provided by University Hospital, Tours:
stroke
transient ischemic attack
albuminuria
BNP
Cystatin C

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013