Cerebral Vascular Accident (CVA)NCT01960478
Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke
A study testing (for each intervention) and Blood test in people with Cerebral Vascular Accident (CVA), run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vascular Accident (CVA)
- What is being tested?
- (for each intervention) and Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2014to 5 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- All patients with a contraindication to MRI Scan:
- Pacemaker,
- Implanted cardiac defibrillator,
- Implanted Neuro-stimulator,
- Cochlear Implants
- Implanted Insulin pump
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Urgences Médico-Chirugicales Adultes Hôpitaux Universitaires
Strasbourg, 67098
About this study
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)
- Being tested
- (for each intervention), Blood test
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(for each intervention)Biological
Blood testOther
| Study group | Role | What they receive |
|---|---|---|
| bood test | Other | Not described Receives: Biological: (for each intervention); Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will be followed during 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study start7 Jan 2014
- Primary completion5 Oct 2014
- Study completion5 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Vascular Accident (CVA)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien HARSCOAT, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960478
- Sponsor's protocol ID
- 5476
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2013
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01960478
- Acronym / sponsor ID
- 5476
- Conditions
- Cerebral Vascular Accident (CVA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Jan 2014 (actual)
- Primary completion
- 5 Oct 2014 (actual)
- Study completion
- 5 Oct 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bood test | Other | Biological: (for each intervention), Other: Blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (16 listed)
- Pacemaker,
- Implanted cardiac defibrillator,
- Implanted Neuro-stimulator,
- Cochlear Implants
- Implanted Insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (for each intervention) | Biological | bood test |
| Blood test | Other | bood test |
Primary outcome
Determine the minimum level of Copeptin required to determine if the patients present with acute CVA or not.
Time frame: Participants will be followed during 90 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien HARSCOAT principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (for each intervention) and Blood test in people with Cerebral Vascular Accident (CVA), run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the minimum level of Copeptin required to determine if the patients present with acute CVA or not. (time frame: Participants will be followed during 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.