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Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

Primary Purpose

Cerebral Vascular Accident (CVA)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
(for each intervention)
Blood test
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebral Vascular Accident (CVA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

bood test

Arm Description

Outcomes

Primary Outcome Measures

Determine the minimum level of Copeptin required to determine if the patients present with acute CVA or not.
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

Secondary Outcome Measures

Full Information

First Posted
September 25, 2013
Last Updated
March 4, 2021
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT01960478
Brief Title
Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke
Official Title
Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2014 (Actual)
Primary Completion Date
October 5, 2014 (Actual)
Study Completion Date
October 5, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Vascular Accident (CVA)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bood test
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
(for each intervention)
Intervention Type
Other
Intervention Name(s)
Blood test
Primary Outcome Measure Information:
Title
Determine the minimum level of Copeptin required to determine if the patients present with acute CVA or not.
Description
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
Time Frame
Participants will be followed during 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien HARSCOAT
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Learn more about this trial

Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

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