Completed

Cytokine and Leukocyte Activation Profile as a Risk Factor for Cerebral Vascular Disease and Stroke

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What is being tested

cytokine and leukocyte activation profile

Procedure
Who is being recruted

Arterial Occlusive Diseases+20

+ Arteriosclerosis

+ Brain Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 1993
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1993

Actual date on which the first participant was enrolled.

Preliminary studies indicate that activation of the immune system by risk factors for stroke (hypertension, hypercholesterolemia, diabetes and age) increases the risk of atherosclerosis and the formation of intravascular thrombosis. By measuring the levels of cytokine and leukocyte activation in the stroke prone population and age matched controls without risk factors, an attempt will be made to characterize those factors which potentially increase the risk for carotid atherosclerosis and subsequent cerebral infarctions. A total of one hundred twenty subjects with risk factors for stroke and forty controls will be enrolled over a two year period and followed for one year. All subjects will have blood drawn at the time of enrollment, at six months, and one year to measure cytokine levels (including Interleukin-I, Tumor Necrosis Factor-Alpha, Interleukin-8) and leukocyte activation/receptor (including Intercellular Adhesion Molecule-1 (ICAM-1), Endothelial Leukocyte Adhesion Molecule-1 (ELAM-1), V-Cell Adhesion Molecule (VCAM), and Macrophage Antigen-1). Carotid dopplers will be performed at the time of enrollment and at one year. An analysis will be performed to: 1) determine if patients with risk factors for stroke have an increased activation of baseline cytokine levels and leukocytes, 2) determine if patients who have stroke risk factors and are symptomatic have an increased activation of cytokines and leukocyte vs. asymptomatic patients, and 3) determine if patients with increased cytokine/leukocyte activity have accelerated atherosclerosis of the carotid arteries.

NCT00001368
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersEndocrine System DiseasesHyperlipidemiasMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesVascular DiseasesGlucose Metabolism DisordersDyslipidemiasLipid Metabolism DisordersCarotid Artery DiseasesBrain IschemiaDiabetes MellitusHypercholesterolemiaHypertensionCarotid StenosisStrokeAtherosclerosis

Criteria

Male or female greater than 18 years of age. Patient must have documented hypertension (diastolic BP greater than 90 mmHg or systolic BP greater than 140 mmHg) for greater than 1 year OR hypercholesterolemia (LDL greater than 160 or total Chol greater than 240 with a total cholesterol/HDL-Chol ratio more than 1.6 for greater that 1 year OR Diabetes (blood glucose greater than 150 mg/dl requiring oral antihyperglycemics or insulin dependent) for greater than 1 year OR any combination. Subgroup eligibility for risk factors with cerebral ischemic events must meet criteria #2 plus documented stroke by physical exam and CT and/or MRI consistent with ischemic infarction or TIA witnessed and recorded by medical personnel. Patient will be excluded if enrollment time is within 30 days of a stroke, myocardial infarction, or surgery. Patient may be enrolled after 30 days of the above events. No patients on immunosuppressive therapy. No patients who are unable to follow up for 1 year from the time of enrollment. No stroke patients with an identifiable cardiac source (including atrial fibrillation, mural thrombus, valvular disease with vegetation).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, United StatesOpen National Institute of Neurological Disorders and Stroke (NINDS) in Google Maps
CompletedOne Study Center