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CompletedNCT01960478Updated Mar 9, 2021

Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

An interventional study of (for each intervention) and Blood test in Cerebral Vascular Accident (CVA), sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Vascular Accident (CVA)
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's enrollment of 150 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Other
    bood test

    Biological: (for each intervention) · Other: Blood test

Interventions

  • Biological(for each intervention)
  • OtherBlood test
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Participants will be followed during 90 days

07

Study locations

1 site
  • Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires
    Strasbourg, 67098, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01960478
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Oct 10, 2013
Start date
Jan 7, 2014
Primary completion
Oct 5, 2014
Completion
Oct 5, 2014
Last update
Mar 9, 2021

Study contacts

Sébastien HARSCOAT
principal investigator · Hôpitaux Universitaires de Strasbourg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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