Inflammatory Biomarkers as Tool in Diagnosis and Management of Patients With Ischemic Stroke

Cerebrovascular Accident Clinical Trial

Official title:

Inflammatory Biomarkers as Additional Tool to Neuroimaging in the Diagnosis and Management of Patients With Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01787877
• Other study ID #: 0064-12-ZIV
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: February 6, 2013
• Start date: February 2013

Study information

• Verified date: February 2013
• Source: Ziv Hospital
• Contact: Saad Abu Saleh, MD
• Phone: +972508434152
• Email: saad.a[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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. 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.

Other known NCT identifiers

• NCT01787890

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Follow-up 1 year	No
Secondary	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	Follow-up for 1 year	No