CClinicalTrials.gg
Status unknownNCT01787877Updated Feb 11, 2013

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

An observational study in Cerebrovascular Accident, sponsored by Ziv Hospital. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-02-11.

Sponsored by Ziv Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebrovascular Accident

Keywords

  • Cerebrovascular Accident, Inflammatory biomarkers
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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 50 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Ziv Hospital is the lead sponsor of 82 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with CVA reporting to the Hospital Emergency Room

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Stroke patients reporting to the ER
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: Follow-up for 1 year

07

Study locations

1 site
  • Ziv Medical Center
    Safed, 13000, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01787877
Lead sponsor
Ziv Hospital
Responsible party
Saad Abu Saleh (Medical Sub Investigator, Ziv Hospital) — Principal investigator
First posted
Feb 11, 2013
Start date
Feb 2013
Primary completion
Aug 2013 (estimated)
Last update
Feb 11, 2013

Study contacts

Saad Abu Saleh, MD
Contact
saad.a@ziv.health.gov.il
+972508434152
Karine Beiruti, PhD
Contact
karine.b@ziv.health.gov.il
+97246828208
Saad Abu Saleh, MD
study director · Ziv Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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