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Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01960478
First received: September 25, 2013
Last updated: October 10, 2013
Last verified: October 2013

September 25, 2013
October 10, 2013
October 2013
March 2016   (final data collection date for primary outcome measure)
Determine the minimum level of Copeptin required to determine if the patients present with acute CVA or not. [ Time Frame: Participants will be followed during 90 days ] [ Designated as safety issue: Yes ]
Copeptin is associated with acute endogenous stress. It seems to have interesting potential in the diagnosis of CVA by its negative predictive value like D-dimers in pulmonary embolism. Proadrenomedullin and Brain Natriuretic Peptide (BNP) are both associated with the prognosis of cardio-vascular diseases and could be interesting in evaluating CVA prognosis
Same as current
Complete list of historical versions of study NCT01960478 on ClinicalTrials.gov Archive Site
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Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke
Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

In the USA, every year 795,000 patients suffer a cerebral vascular accident (CVA), which represents a yearly cost of $73.7 billion. CVA is the third main cause of death and the main source of acquired handicap in adults, as a result it is now a key priority in public health and part of " The CVA National Action Plan 2013-2014".

Copeptin is a polypeptide, by- product of Vasopressin metabolism. The increase of Copeptin plasma level, as for Vasopressin, is connected to hydric balance disorders found in cardio-vascular, renal and endocrine diseases. This link has already shown its interest in the early diagnosis of myocardial infarction and, in a more indirect way, CVA.

Copeptin is associated with acute endogenous stress. It seems to have interesting potential in the diagnosis of CVA by its negative predictive value like D-dimeres in pulmonary embolism. Proadrenomedullin and Brain Natriuretic Peptide (BNP) are both associated with the prognosis of cardio-vascular diseases and could be interesting in evaluating CVA prognosis.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cerebral Vascular Accident (CVA)
  • Biological: (for each intervention)
  • Other: Blood test
bood test
Interventions:
  • Biological: (for each intervention)
  • Other: Blood test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
Not Provided
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients, male or female, may be included if they meet the following criteria:
  • patients with suspected ischemic CVA admitted in an acute stroke unit (thrombolysis unit).
  • aged 18 and over.
  • MRI Scan undertaken under the current protocol which includes the following sequences: distribution, T2* (gradient echo), ARM, TOF and FLAIR.
  • after information given the consent form is signed:

    • by the patient .or for those unable to express their consent (in case of coma or severe neurological disorder) by a relative or next of kin.

.the patient will be informed as soon as he has recovered his faculties in order to be able to express, if he wishes, his opposition to the pursuit of the research (sample destruction before tested).

- the patient must be registered with the Social Security

Exclusion Criteria:

All patients with a contraindication to MRI Scan:

  • Pacemaker,
  • Implanted cardiac defibrillator,
  • Implanted Neuro-stimulator,
  • Cochlear Implants
  • Implanted Insulin pump
  • Other implanted electronic medical device
  • Vascular intracerebral Clip
  • Cardiac Valve
  • Other metallic implant
  • Metallic foreign body
  • Ventricular diversion valve
  • Eye or hearing prosthesis
  • Current or suspected pregnancy
  • Breast feeding

Those who are under protection of justice, under guardianship or curatorship will also be excluded.

Both
18 Years and older
No
Contact: Sébastien HARSCOAT 3 69 55 13 70 ext 0033 sebastien.harscoat@chru-strasbourg.fr
France
 
NCT01960478
5476
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Sébastien HARSCOAT Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP