Cardiology Prevention in Systemic Lupus Erythematosus (SLE)
Summary
We propose a feasibility study of aggressive CV risk factor management directed by preventive cardiology compared to usual care. We will determine: 1) the efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals.
We hypothesize Lupus patients randomized to the preventive cardiology program will have less cardiovascular progression over two years than those lupus patients who are given standard care for cardiovascular risk, defined by carotid intima-media thickness and plaque.
Description
We will recruit 30 eligible patients from the Lupus Center of Excellence outpatient clinic. Patients will either be randomized into a preventive cardiology program for aggressive treatment, or randomized to usual care (1:1 ratio) in a single-blinded, randomized trial of 24 months duration. In this feasibility trial we hope to identify and refine any limitations in anticipation of designing a larger, randomized intervention study.
For both arms of the study, at baseline, 6 month, 12 month, 18 month, and 24 month visits (5 visits in total) all patients will be seen by Dr. Elliott, Principal Investigator. Visits will include an interview, fasting laboratory tests completion of questionnaires regarding demographics, socioeconomic status, health status, and risk factors (traditional, inflammatory, and lupus-specific). Dr. Elliott will perform the physical examinations on all patients and complete the lupus-specific disease activity and damage questionnaires. At the Baseline visit, 12-month visit, and 24 24-month visits, all patients will have a carotid ultrasound.
Cohort 1: Preventive Cardiology Program arm: Above and beyond the standard care, which is listed below, the patients in this arm will be aggressively treated by the cardiologist. As deemed prudent, the following may be prescribed: antihypertensives, lipid reducing agents, anti-platelets, further cardiac testing, and behavioral modifications. No standard care treatment will be withheld.
Cohort 2: Standard Care arm: The PI will send a letter of all testing results to their designated PCP. No standard care treatment will be withheld.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Conditions
Systemic Lupus Erythematosus
Intervention
Preventive Cardiology, Usual Care
Location
Lupus Center of Excellence, Magee Womens Hospital, 300 Halket St, Suite 1750
Pittsburgh
Pennsylvania
United States
15213
Status
Not yet recruiting
Source
University of Pittsburgh
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00610805
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lupus Erythematosus, Cutaneous
A form of lupus erythematosus in which the skin may be the only organ involved or in which skin involvement precedes the spread into other body systems. It has been classified into three forms - acute (= LUPUS ERYTHEMATOSUS, SYSTEMIC with skin lesions), subacute, and chronic (= LUPUS ERYTHEMATOSUS, DISCOID).
Lupus Erythematosus, Discoid
A chronic form of cutaneous lupus erythematosus (LUPUS ERYTHEMATOSUS, CUTANEOUS) in which the skin lesions mimic those of the systemic form but in which systemic signs are rare. It is characterized by the presence of discoid skin plaques showing varying degrees of edema, erythema, scaliness, follicular plugging, and skin atrophy. Lesions are surrounded by an elevated erythematous border. The condition typically involves the face and scalp, but widespread dissemination may occur.
Antibodies, Anticardiolipin
Antiphospholipid antibodies found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. The antibodies are detected by solid-phase IMMUNOASSAY employing the purified phospholipid antigen CARDIOLIPIN.
Lupus Coagulation Inhibitor
An antiphospholipid antibody found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. In vitro, the antibody interferes with the conversion of prothrombin to thrombin and prolongs the partial thromboplastin time. In vivo, it exerts a procoagulant effect resulting in thrombosis mainly in the larger veins and arteries. It further causes obstetrical complications, including fetal death and spontaneous abortion, as well as a variety of hematologic and neurologic complications.
Antibodies, Antiphospholipid
Autoantibodies directed against phospholipids. These antibodies are characteristically found in patients with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; related autoimmune diseases, some non-autoimmune diseases, and also in healthy individuals.
Clinical Trials
Study of GL701 in Men With Systemic Lupus Erythematosus
Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug mea...
Feasibility and Safety of Acupuncture for Systemic Lupus
The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly t...
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus. II. Evaluate objective disease parameters, including serum complement levels...
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
Study Evaluating the SBI-087 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
PubMed Articles
Cardiac tamponade as an initial manifestation of systemic lupus erythematosus in a child.
Cardiac involvement is a rare initial presentation of systemic lupus erythematosus. An 11-year-old girl was described to have massive haemorrhagic pericardial effusion and cardiac tamponade, which was...
Systemic lupus erythematosus complicated with pulmonary hemorrhage in a 17-year old girl.
Pulmonary hemorrhage is a rare and life-threatening complication of systemic lupus erythematosus. In this report, we described a 17-year-old female with pulmonary hemorrhage as an initial manifestatio...
Hydroxychloroquine is used extensively in the treatment of systemic lupus erythematosus, not only for its benefit for cutaneous and musculoskeletal lupus, but also for its role in preventing flares, p...
Many immunedeficiency syndromes are associated with autoimmune disorders. We here report on a girl with a systemic lupus erythematosus-like disease who suffered from both hyperimmunoglobulin M syndrom...
