Lupus Cohort--Thrombotic Events and Coronary Artery Disease
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Thrombosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005436
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005436
Brief Title
Lupus Cohort--Thrombotic Events and Coronary Artery Disease
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
September 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Thrombosis, Heart Diseases, Lupus Erythematosus, Systemic
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
9364831
Citation
Petri M. Antiphospholipid antibody syndrome: an acquired cause of venous and arterial hypercoagulability. Mt Sinai J Med. 1997 Nov;64(6):376-82.
Results Reference
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PubMed Identifier
7480688
Citation
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.
Results Reference
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PubMed Identifier
9153538
Citation
Petri M, Robinson C. Oral contraceptives and systemic lupus erythematosus. Arthritis Rheum. 1997 May;40(5):797-803. doi: 10.1002/art.1780400504.
Results Reference
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PubMed Identifier
8869905
Citation
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.
Results Reference
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PubMed Identifier
9031371
Citation
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.
Results Reference
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PubMed Identifier
8970042
Citation
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.
Results Reference
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PubMed Identifier
9012759
Citation
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.
Results Reference
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PubMed Identifier
8961910
Citation
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.
Results Reference
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PubMed Identifier
8888164
Citation
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.
Results Reference
background
PubMed Identifier
8803905
Citation
Petri M. Hydroxychloroquine use in the Baltimore Lupus Cohort: effects on lipids, glucose and thrombosis. Lupus. 1996 Jun;5 Suppl 1:S16-22.
Results Reference
background
PubMed Identifier
7562773
Citation
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.
Results Reference
background
PubMed Identifier
9101497
Citation
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.
Results Reference
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PubMed Identifier
8643681
Citation
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.
Results Reference
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PubMed Identifier
7654797
Citation
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.
Results Reference
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PubMed Identifier
7651650
Citation
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.
Results Reference
background
PubMed Identifier
7929693
Citation
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.
Results Reference
background
PubMed Identifier
7826694
Citation
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.
Results Reference
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PubMed Identifier
8154514
Citation
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.
Results Reference
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PubMed Identifier
7869307
Citation
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.
Results Reference
background
PubMed Identifier
8148276
Citation
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.
Results Reference
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PubMed Identifier
8341140
Citation
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.
Results Reference
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PubMed Identifier
8496859
Citation
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.
Results Reference
background
PubMed Identifier
8153405
Citation
Petri M. Systemic lupus erythematosus and pregnancy. Rheum Dis Clin North Am. 1994 Feb;20(1):87-118.
Results Reference
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Lupus Cohort--Thrombotic Events and Coronary Artery Disease
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