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

NCT ID: NCT01787877

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28

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.

Conditions

Cerebrovascular Accident

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke patients reporting to the ER

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Saad Abu Saleh

Medical Sub Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saad Abu Saleh, MD

Role: STUDY_DIRECTOR

Ziv Medical Center

Locations

Ziv Medical Center

Safed, , Israel

Countries

Israel

Central Contacts

Saad Abu Saleh, MD

Role: CONTACT

saad.a@ziv.health.gov.il

+972508434152

Karine Beiruti, PhD

Role: CONTACT

karine.b@ziv.health.gov.il

+97246828208

Facility Contacts

Radi Shahien, MD

Role: primary

radi.s@ziv.health.gov.il

+972508438927

Other Identifiers

0064-12-ZIV

Identifier Type: -

Identifier Source: org_study_id

NCT01787890

Identifier Type: -

Identifier Source: nct_alias