Cardiovascular Diseases Clinical Trial
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).
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.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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