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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. The completion date has passed and the status has not been verified in more than two years.
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Service de Neurologie / Hopital LAENNEC
Nantes, France, 44093
Service de neurologie / CHU Pontchaillou
Rennes, France, 35033
Service de Neurologie / CHRU de Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: BONNAUD Isabelle, MD Service de Neurologie / CHRU de Tours
  More Information

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:
Stroke
Ischemia
Cerebral Infarction
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on December 05, 2016