Clinical trial NCT01787877: Inflammatory Biomarkers as Tool in Diagnosis and Management of Patients With Ischemic Stroke
Official title: Inflammatory Biomarkers as Additional Tool to Neuroimaging in the Diagnosis and Management of Patients With Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Accident
Keywords: Cerebrovascular Accident, Inflammatory biomarkers
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CVA reporting to the Hospital Emergency Room

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
2. Diagnosis of acute clinical stroke
3. Ages 18 and above inclusive
4. Both genders eligible for the study

Exclusion Criteria:

1. Intracerebral hemorrhage according to Computed Tomography (CT)
2. Clinical signs of infection on admission
3. Patients with chronic inflammatory disease
4. Hematologic disorders (anemia)
5. Malignant tumor
6. Renal or hepatic failure
7. Treatment with anti-inflammatory or corticosteroids drugs within a month before stroke

Primary outcomes:
measure: Relationship between inflammatory biomarkers and CVA patients
timeFrame: Follow-up 1 year
Secondary outcomes:
measure: Identify patients at risk of recurrent stroke by identifying molecular biomarkers
timeFrame: Follow-up for 1 year
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Saad Abu Saleh, MD
role: STUDY_DIRECTOR
References: