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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01787877
Enrollment
50
Registered
2013-02-11
Start date
2013-02-28
Completion date
Unknown
Last updated
2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Keywords

Cerebrovascular Accident, Inflammatory biomarkers

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.

Interventions

None listed

Sponsors

Ziv Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between inflammatory biomarkers and CVA patientsFollow-up 1 yearTo 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

Secondary

MeasureTime frameDescription
Identify patients at risk of recurrent stroke by identifying molecular biomarkersFollow-up for 1 yearTo develop specific molecular biomarkers to support the clinical diagnosis, identify patients at risk of recurrent stroke and select the appropriate treatment

Countries

Israel

Contacts

Primary ContactSaad Abu Saleh, MD
saad.a@ziv.health.gov.il+972508434152
Backup ContactKarine Beiruti, PhD
karine.b@ziv.health.gov.il+97246828208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026