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.

Study Overview

• Status: Completed
• Conditions: Cerebral Vascular Accident (CVA)
• Intervention / Treatment: Biological: (for each intervention); Other: Blood test

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: bood test	Biological: (for each intervention); Other: Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Participants will be followed during 90 days

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Sébastien HARSCOAT, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2014
• Primary Completion (ACTUAL): October 5, 2014
• Study Completion (ACTUAL): October 5, 2014

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (ESTIMATE): October 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 5476