Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005436
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Lupus Cohort--Thrombotic Events and Coronary Artery Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL047080 | NIH | None | httpsreporternihgovquickSearchR29HL047080 |