Lupus Cohort--Thrombotic Events and Coronary Artery Disease
NCT ID: NCT00005436
Last Updated: 2016-02-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Study Classification
OBSERVATIONAL
Study Start Date
1991-09-30
Study Completion Date
1996-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Systemic Lupus Erythematosus
NCT00001372
Systemic Lupus Erythematosus
RECRUITING
Insulin Resistance and Atherosclerosis in Women With Lupus
NCT00544102
Systemic Lupus Erythematosus
Insulin Resistance
Atherosclerosis
COMPLETED
Relation of Antibodies Against Oxidized Low Density Lipoproteins to Disease Activity and Cardiovascular Affection in Systemic Lupus.
NCT05479071
SLE
UNKNOWN
Cardiology Prevention in Systemic Lupus Erythematosus (SLE)
NCT00610805
Systemic Lupus Erythematosus
WITHDRAWN
NA
Atherosclerosis in Rheumatoid Arthritis and Lupus: Restoring Cholesterol Balance
NCT01180361
Rheumatoid Arthritis
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cardiovascular Diseases
Coronary Disease
Thrombosis
Heart Diseases
Lupus Erythematosus, Systemic
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
No eligibility criteria
Maximum Eligible Age
100 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
lead
References
Explore related publications, articles, or registry entries linked to this study.
Petri M. Antiphospholipid antibody syndrome: an acquired cause of venous and arterial hypercoagulability. Mt Sinai J Med. 1997 Nov;64(6):376-82.
Reference Type
BACKGROUND
Bluemke DA, Petri M, Zerhouni EA. Femoral head perfusion and composition: MR imaging and spectroscopic evaluation of patients with systemic lupus erythematosus and at risk for avascular necrosis. Radiology. 1995 Nov;197(2):433-8. doi: 10.1148/radiology.197.2.7480688.
Reference Type
BACKGROUND
Petri M, Robinson C. Oral contraceptives and systemic lupus erythematosus. Arthritis Rheum. 1997 May;40(5):797-803. doi: 10.1002/art.1780400504.
Reference Type
BACKGROUND
Dunn JP, Noorily SW, Petri M, Finkelstein D, Rosenbaum JT, Jabs DA. Antiphospholipid antibodies and retinal vascular disease. Lupus. 1996 Aug;5(4):313-22. doi: 10.1177/096120339600500413.
Reference Type
BACKGROUND
Petri M. Hopkins Lupus Pregnancy Center: 1987 to 1996. Rheum Dis Clin North Am. 1997 Feb;23(1):1-13. doi: 10.1016/s0889-857x(05)70311-2.
Reference Type
BACKGROUND
Sullivan KE, Wisnieski JJ, Winkelstein JA, Louie J, Sachs E, Choi R, Veksler E, Goldman D, Petri M. Serum complement determinations in patients with quiescent systemic lupus erythematosus. J Rheumatol. 1996 Dec;23(12):2063-7.
Reference Type
BACKGROUND
Petri M. Pathogenesis and treatment of the antiphospholipid antibody syndrome. Med Clin North Am. 1997 Jan;81(1):151-77. doi: 10.1016/s0025-7125(05)70509-5.
Reference Type
BACKGROUND
Sullivan KE, Wooten C, Goldman D, Petri M. Mannose-binding protein genetic polymorphisms in black patients with systemic lupus erythematosus. Arthritis Rheum. 1996 Dec;39(12):2046-51. doi: 10.1002/art.1780391214.
Reference Type
BACKGROUND
Petri M, Roubenoff R, Dallal GE, Nadeau MR, Selhub J, Rosenberg IH. Plasma homocysteine as a risk factor for atherothrombotic events in systemic lupus erythematosus. Lancet. 1996 Oct 26;348(9035):1120-4. doi: 10.1016/S0140-6736(96)03032-2.
Reference Type
BACKGROUND
Petri M. Hydroxychloroquine use in the Baltimore Lupus Cohort: effects on lipids, glucose and thrombosis. Lupus. 1996 Jun;5 Suppl 1:S16-22.
Reference Type
BACKGROUND
Petri M, Ho AC, Patel J, Demers D, Joseph JM, Goldman D. Elevation of maternal alpha-fetoprotein in systemic lupus erythematosus: a controlled study. J Rheumatol. 1995 Jul;22(7):1365-8.
Reference Type
BACKGROUND
Mont MA, Glueck CJ, Pacheco IH, Wang P, Hungerford DS, Petri M. Risk factors for osteonecrosis in systemic lupus erythematosus. J Rheumatol. 1997 Apr;24(4):654-62.
Reference Type
BACKGROUND
Casciola-Rosen L, Rosen A, Petri M, Schlissel M. Surface blebs on apoptotic cells are sites of enhanced procoagulant activity: implications for coagulation events and antigenic spread in systemic lupus erythematosus. Proc Natl Acad Sci U S A. 1996 Feb 20;93(4):1624-9. doi: 10.1073/pnas.93.4.1624.
Reference Type
BACKGROUND
Petri M. Musculoskeletal complications of systemic lupus erythematosus in the Hopkins Lupus Cohort: an update. Arthritis Care Res. 1995 Sep;8(3):137-45. doi: 10.1002/art.1790080305.
Reference Type
BACKGROUND
Johnson MJ, Petri M, Witter FR, Repke JT. Evaluation of preterm delivery in a systemic lupus erythematosus pregnancy clinic. Obstet Gynecol. 1995 Sep;86(3):396-9. doi: 10.1016/0029-7844(95)00186-U.
Reference Type
BACKGROUND
Bermas BL, Petri M, Goldman D, Mittleman B, Miller MW, Stocks NI, Via CS, Shearer GM. T helper cell dysfunction in systemic lupus erythematosus (SLE): relation to disease activity. J Clin Immunol. 1994 May;14(3):169-77. doi: 10.1007/BF01533366.
Reference Type
BACKGROUND
Bermas BL, Petri M, Berzofsky JA, Waisman A, Shearer GM, Mozes E. Binding of glycoprotein 120 and peptides from the HIV-1 envelope by autoantibodies in mice with experimentally induced systemic lupus erythematosus and in patients with the disease. AIDS Res Hum Retroviruses. 1994 Sep;10(9):1071-7. doi: 10.1089/aid.1994.10.1071.
Reference Type
BACKGROUND
Petri M, Lakatta C, Magder L, Goldman D. Effect of prednisone and hydroxychloroquine on coronary artery disease risk factors in systemic lupus erythematosus: a longitudinal data analysis. Am J Med. 1994 Mar;96(3):254-9. doi: 10.1016/0002-9343(94)90151-1.
Reference Type
BACKGROUND
Utset TO, Golden M, Siberry G, Kiri N, Crum RM, Petri M. Depressive symptoms in patients with systemic lupus erythematosus: association with central nervous system lupus and Sjogren's syndrome. J Rheumatol. 1994 Nov;21(11):2039-45.
Reference Type
BACKGROUND
Watson RM, Scheel JN, Petri M, Kan JS, Provost TT, Ratrie H 3rd, Callan NA. Neonatal lupus erythematosus. Report of serological and immunogenetic studies in twins discordant for congenital heart block. Br J Dermatol. 1994 Mar;130(3):342-8. doi: 10.1111/j.1365-2133.1994.tb02931.x.
Reference Type
BACKGROUND
Petri M, Watson R, Winkelstein JA, McLean RH. Clinical expression of systemic lupus erythematosus in patients with C4A deficiency. Medicine (Baltimore). 1993 Jul;72(4):236-44. doi: 10.1097/00005792-199307000-00003.
Reference Type
BACKGROUND
Petri M, Allbritton J. Fetal outcome of lupus pregnancy: a retrospective case-control study of the Hopkins Lupus Cohort. J Rheumatol. 1993 Apr;20(4):650-6.
Reference Type
BACKGROUND
Petri M. Systemic lupus erythematosus and pregnancy. Rheum Dis Clin North Am. 1994 Feb;20(1):87-118.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4364
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)
NCT00054938
COMPLETED
PHASE2
Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
NCT04276701
RECRUITING
NA
The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
NCT05440422
RECRUITING
PHASE2
Cardiac and Laboratory Findings in Patients With Systemic Lupus Erythematosus
NCT03179046
COMPLETED
Systemic Lupus Erythematous and Heart Conduction Disorders
NCT02162992
COMPLETED
Lupus Atherosclerosis Prevention Study
NCT00120887
COMPLETED
PHASE4
Anti-nucleosome B Lymphocytes in Lupus
NCT01889654
TERMINATED
Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus
NCT04580108
COMPLETED
Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart Disease
NCT00188188
UNKNOWN
PHASE4
Disease Progression and Activity in Patients With Systemic Lupus Erythematosus
NCT00339261
COMPLETED
Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus
NCT05146414
COMPLETED
Regulatory BCells in Systemic Lupus Erythematosus
NCT03178721
UNKNOWN
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
NCT07340463
RECRUITING
PHASE2
Myocardial Inflammation in Systemic Lupus Erythematosus
NCT01761422
ACTIVE_NOT_RECRUITING
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
NCT00739050
TERMINATED
PHASE4
Catalytic Antibodies and Lupus in Martinique
NCT01157468
COMPLETED
Argentinian Prospective Registry of Patients With Lupus
NCT05470569
RECRUITING
Haematological Indices in Systemic Lupus Erythematosus
NCT04110184
UNKNOWN
Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
NCT00004663
COMPLETED
Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus
NCT00858884
WITHDRAWN
NA
Serologically Active, Clinically Stable Systemic Lupus Erythematosus
NCT00000421
COMPLETED
PHASE2
Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
NCT02338999
COMPLETED
PHASE1/PHASE2
Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment
NCT07102030
RECRUITING
Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
NCT00519363
COMPLETED
PHASE1/PHASE2
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus
NCT05443516
RECRUITING