Potential Risk Factors for Stroke

Phase 1

Completed

• Conditions: Carotid Atherosclerosis; Cerebrovascular Accident; Diabetes Mellitus; Hypercholesterolemia; Hypertension

• Registration Number: NCT00001368
• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Brief Summary

Early studies have shown that the immune system may play a role in the development of strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can activate the immune system and increase the risk of developing hardening of the arteries (atherosclerosis) and damaged blood vessels.

Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system, cytokines and leukocyte activation. Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke. Researchers will measure the immune system components at the beginning of the study, at six months, and at the one-year completion of the study.

The study will attempt to determine;

I) If patients with risk factors for stroke have an increased activation of the immune system

II) If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms

III) If patients with increased activation of the immune system have accelerated hardening of the arteries (atherosclerosis)

Detailed Description

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.

Study Timeline

• Study Start: 1993-10
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Status Verified: 2002-11
• Study Completion: 2002-11
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute of Neurological Disorders and Stroke (NINDS); 🇺🇸 Bethesda, Maryland, United States