Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

NCT ID: NCT01960478

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-07
• Study Completion Date: 2014-10-05

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.

Conditions

Cerebral Vascular Accident (CVA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

bood test

Group Type: OTHER

(for each intervention)

Intervention Type: BIOLOGICAL

Blood test

Intervention Type: OTHER

Interventions

(for each intervention)

Intervention Type: BIOLOGICAL

Blood test

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien HARSCOAT

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires

Strasbourg, , France

Countries

France

Other Identifiers

5476

Identifier Type: -

Identifier Source: org_study_id