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Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01960478
Recruitment Status : Unknown
Verified October 2013 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Cerebral Vascular Accident (CVA) Biological: (for each intervention) Other: Blood test

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke
Study Start Date : October 2013
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
bood test Biological: (for each intervention) Other: Blood test


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960478


Contacts
Contact: Sébastien HARSCOAT 3 69 55 13 70 ext 0033 sebastien.harscoat@chru-strasbourg.fr

Locations
France
Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires Not yet recruiting
Strasbourg, France, 67098
Contact: Sébastien HARSCOAT    03 69 55 13 70 ext 0033    sebastien.harscoat@chru-strasbourg.fr   
Sub-Investigator: Valérie WOLFF         
Sub-Investigator: Christian MARESCAUX         
Sub-Investigator: Valérie LAUER         
Sub-Investigator: Pascal BILBAULT         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Sébastien HARSCOAT Hôpitaux Universitaires de Strasbourg
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01960478     History of Changes
Other Study ID Numbers: 5476
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases