Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

NCT01960478 | Completed

• 1 other identifier: 5476
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

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

  Participants will be followed during 90 days

Study Arms (1)

bood test

OTHER

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

Interventions

(for each intervention) BIOLOGICAL

bood test

Blood test OTHER

bood test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Sébastien HARSCOAT

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 10, 2013
• Study Start: January 7, 2014
• Primary Completion: October 5, 2014
• Study Completion: October 5, 2014
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

FR (1)