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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005436 |
To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).
Condition |
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Cardiovascular Diseases Coronary Disease Thrombosis Heart Diseases Lupus Erythematosus, Systemic |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | September 1991 |
Estimated Study Completion Date: | August 1996 |
BACKGROUND:
The Johns Hopkins Lupus Cohort, begun by Dr. Petri in 1987, was a longitudinal study of the incidence and pathogenesis of thrombotic events and coronary artery disease in SLE. The usual natural history of thrombotic events and coronary artery disease is telescoped in SLE, so that patients present with these outcomes in their third and fourth decades.
DESIGN NARRATIVE:
Risk factors addressed in the study included: 1) the hypercoagulable state secondary to antiphospholipid antibodies (the lupus anticoagulant and anticardiolipin antibody); 2) premature atherosclerosis, accelerated by prednisone and hypertension; 3) underlying vascular damage from lupus vasculopathy and vasculitis; 4) co-morbid factors, including obesity, smoking, hyperlipidemia, hypertension, sedentary life style, and family history of coronary artery disease, and 5) other factors, including sex, age, race, immunogenetics, compliance with medication, and socioeconomic status. The Hopkins Cohort Study was uniquely able to focus on these issues, both because of its population, which reflected a broad racial, educational, and socioeconomic background, and because the four years of data accumulated showed promising preliminary results.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 4364 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005436 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Heart Diseases Autoimmune Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis |
Thrombosis Coronary Disease Embolism and Thrombosis Lupus Erythematosus, Systemic Embolism Connective Tissue Diseases Coronary Artery Disease |
Immune System Diseases Cardiovascular Diseases |