Clinical Trials Directory

Trials / Completed

CompletedNCT00005436

Lupus Cohort--Thrombotic Events and Coronary Artery Disease

Status
Completed
Phase
Study type
Observational
Enrollment
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Sex
Male
Age
100 Years
Healthy volunteers
Not accepted

Summary

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).

Detailed description

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.

Conditions

Timeline

Start date
1991-09-01
Completion
1996-08-01
First posted
2000-05-26
Last updated
2016-02-18

Source: ClinicalTrials.gov record NCT00005436. Inclusion in this directory is not an endorsement.