Cerebrovascular AccidentNCT01787877
Inflammatory Biomarkers as Tool in Diagnosis and Management of Patients With Ischemic Stroke
An observational study of Cerebrovascular Accident, run by Ziv Hospital at 1 site in Israel.
Trial summary
Stroke represents the third commonest cause of death after heart disease and all types of cancer combined, and is the leading cause of long-term permanent disability among adults. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Aug 2013
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CVA reporting to the Hospital Emergency Room
Who may be able to join
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Diagnosis of acute clinical stroke
- Ages 18 and above inclusive
- Both genders eligible for the study
Who cannot join
- Intracerebral hemorrhage according to Computed Tomography (CT)
- Clinical signs of infection on admission
- Patients with chronic inflammatory disease
- Hematologic disorders (anemia)
- Malignant tumor
- Renal or hepatic failure
- Treatment with anti-inflammatory or corticosteroids drugs within a month before stroke
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv Medical Center
Safed, 13000
Radi Shahien, MD, +972508438927, radi.s@ziv.health.gov.il
Radi Shahien, MD
About this study
Official title: Inflammatory Biomarkers as Additional Tool to Neuroimaging in the Diagnosis and Management of Patients With Ischemic Stroke
Stroke represents the third commonest cause of death after heart disease and all types of cancer combined, and is the leading cause of long-term permanent disability among adults. Recombinant tissue plasminogen activator (tPA) is currently the only safe medical treatment for acute ischemic stroke but only a small fraction of patients are eligible for a thrombolysis treatment. Current guidelines on thrombolysis post stroke with tPA exclude its uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many patients from potentially beneficial treatment.
For an appropriate triage and management of patients, it is essential to improve imaging techniques beyond a simple CT scan. Perfusion computed tomography (PCT), currently considered as an investigational technique, permits a quantitative determination of the cerebral perfusion within the brain. It helps distinguish salvageable ischemic penumbra from irreversibly infarcted core in acute stroke patients. This technique has therefore the potential to select patients who are most likely to benefit from thrombolysis with tPA, can be used to predict the benefit after thrombolysis and determine the suitability for other therapeutic interventions. In patients with a primary diagnosis of TIA, PCT would help to identify possible persistent cerebral ischemia but also provide important information for rapid instigation of prophylactic strategies.
The diagnosis and management of patients with ischemic stroke and TIA is challenging and is primarily based on clinical assessment in conjunction with neuroimaging. Development of specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude common stroke mimics such as migraine or epileptic seizures, identify patients at risk of disease, and help guide patient treatment by predicting complications following t-PA treatment would be of great value.
- Conditions
- Cerebrovascular Accident
- Keywords
- Cerebrovascular Accident, Inflammatory biomarkers
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients reporting to the ER | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between inflammatory biomarkers and CVA patients
To assess the levels over the time of selected inflammatory biomarkers, to determine the relationship between them after acute ischemic stroke and to evaluate their correlation with patients characteristics
Measured: Follow-up 1 year
Secondary outcomes (1)
Identify patients at risk of recurrent stroke by identifying molecular biomarkers
To develop specific molecular biomarkers to support the clinical diagnosis, identify patients at risk of recurrent stroke and select the appropriate treatment
Measured: Follow-up for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Saad Abu Saleh, Ziv Hospital
- Investigators
- Saad Abu Saleh, MD, Study director, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787877
- Sponsor's protocol ID
- 0064-12-ZIV
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Biomarkers as Additional Tool to Neuroimaging in the Diagnosis and Management of Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01787877
- Acronym / sponsor ID
- 0064-12-ZIV
- Conditions
- Cerebrovascular Accident
- Keywords
- Cerebrovascular Accident, Inflammatory biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (estimated)
- First posted
- 11 Feb 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.
Stroke represents the third commonest cause of death after heart disease and all types of cancer combined, and is the leading cause of long-term permanent disability among adults. Recombinant tissue plasminogen activator (tPA) is currently the only safe medical treatment for acute ischemic stroke but only a small fraction of patients are eligible for a thrombolysis treatment. Current guidelines on thrombolysis post stroke with tPA exclude its uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many patients from potentially beneficial treatment.
For an appropriate triage and management of patients, it is essential to improve imaging techniques beyond a simple CT scan. Perfusion computed tomography (PCT), currently considered as an investigational technique, permits a quantitative determination of the cerebral perfusion within the brain. It helps distinguish salvageable ischemic penumbra from irreversibly infarcted core in acute stroke patients. This technique has therefore the potential to select patients who are most likely to benefit from thrombolysis with tPA, can be used to predict the benefit after thrombolysis and determine the suitability for other therapeutic interventions. In patients with a primary diagnosis of TIA, PCT would help to identify possible persistent cerebral ischemia but also provide important information for rapid instigation of prophylactic strategies.
The diagnosis and management of patients with ischemic stroke and TIA is challenging and is primarily based on clinical assessment in conjunction with neuroimaging. Development of specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude common stroke mimics such as migraine or epileptic seizures, identify patients at risk of disease, and help guide patient treatment by predicting complications following t-PA treatment would be of great value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients reporting to the ER | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CVA reporting to the Hospital Emergency Room
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Diagnosis of acute clinical stroke
- Ages 18 and above inclusive
- Both genders eligible for the study
Key exclusion criteria (7 listed)
- Intracerebral hemorrhage according to Computed Tomography (CT)
- Clinical signs of infection on admission
- Patients with chronic inflammatory disease
- Hematologic disorders (anemia)
- Malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between inflammatory biomarkers and CVA patients
Time frame: Follow-up 1 year
To assess the levels over the time of selected inflammatory biomarkers, to determine the relationship between them after acute ischemic stroke and to evaluate their correlation with patients characteristics
1 secondary outcome
Identify patients at risk of recurrent stroke by identifying molecular biomarkers
Time frame: Follow-up for 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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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.
Saad Abu Saleh, MD study director
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by Ziv Hospital at 1 site in Israel.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Feb 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saad Abu Saleh, MD (+972508434152, saad.a@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between inflammatory biomarkers and CVA patients (time frame: Follow-up 1 year). 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 11 Feb 2013.