Status:
COMPLETED
Potential Risk Factors for Stroke
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Carotid Atherosclerosis
Cerebrovascular Accident
Eligibility:
All Genders
Phase:
PHASE1
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 s...
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 format...
Eligibility 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).
Key Trial Info
Start Date :
October 1 1993
Trial Type :
INTERVENTIONAL
End Date :
November 1 2002
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00001368
Start Date
October 1 1993
End Date
November 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892