Cardiovascular DiseasesNCT00005436
Lupus Cohort--Thrombotic Events and Coronary Artery Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Thrombosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Aug 1996
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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).
Read the 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
- Cardiovascular Diseases, Coronary Disease, Thrombosis, Heart Diseases, Lupus Erythematosus, Systemic
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Thrombosis, Heart Diseases, Lupus Erythematosus, Systemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1991
- Study completionAug 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005436
- Sponsor's protocol ID
- 4364
- Other IDs
- R29HL047080
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Petri M. Antiphospholipid antibody syndrome: an acquired cause of venous and arterial hypercoagulability. Mt Sinai J Med. 1997 Nov;64(6):376-82.
PubMed 9364831Bluemke 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.
PubMed 7480688Petri M, Robinson C. Oral contraceptives and systemic lupus erythematosus. Arthritis Rheum. 1997 May;40(5):797-803. doi: 10.1002/art.1780400504.
PubMed 9153538Dunn 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.
PubMed 8869905Petri 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.
PubMed 9031371Sullivan 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.
PubMed 8970042Petri 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.
PubMed 9012759Sullivan 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.
PubMed 8961910Petri 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.
PubMed 8888164Petri M. Hydroxychloroquine use in the Baltimore Lupus Cohort: effects on lipids, glucose and thrombosis. Lupus. 1996 Jun;5 Suppl 1:S16-22.
PubMed 8803905Petri 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.
PubMed 7562773Mont 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.
PubMed 9101497Casciola-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.
PubMed 8643681Petri 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.
PubMed 7654797Johnson 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.
PubMed 7651650
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lupus Cohort--Thrombotic Events and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00005436
- Acronym / sponsor ID
- 4364
- Conditions
- Cardiovascular Diseases, Coronary Disease, Thrombosis, Heart Diseases, Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1991
- Study completion
- Aug 1996 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 9364831Petri M. Antiphospholipid antibody syndrome: an acquired cause of venous and arterial hypercoagulability. Mt Sinai J Med. 1997 Nov;64(6):376-82.
- Background: PubMed 7480688Bluemke 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.
- Background: PubMed 9153538Petri M, Robinson C. Oral contraceptives and systemic lupus erythematosus. Arthritis Rheum. 1997 May;40(5):797-803. doi: 10.1002/art.1780400504.
- Background: PubMed 8869905Dunn 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.
- Background: PubMed 9031371Petri 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.
- Background: PubMed 8970042Sullivan 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.
- Background: PubMed 9012759Petri 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.
- Background: PubMed 8961910Sullivan 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.
- Background: PubMed 8888164Petri 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.
- Background: PubMed 8803905Petri M. Hydroxychloroquine use in the Baltimore Lupus Cohort: effects on lipids, glucose and thrombosis. Lupus. 1996 Jun;5 Suppl 1:S16-22.
- Background: PubMed 7562773Petri 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.
- Background: PubMed 9101497Mont 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005436, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.