| City: |
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15261 |
| Conditions: |
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Systemic Lupus Erythematosus |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
1. Definitive diagnosis of SLE
2. >18 years of age
3. Followed by rheumatologists (not the investigator, Dr. Elliott) at the Lupus Center
of Excellence
4. Informed consent signed
5. Effective form of birth control
Exclusion Criteria:
1. Prior cardiovascular disease history (MI, coronary angioplasty, coronary artery
bypass graft, abnormal coronary angiography, abnormal nuclear or treadmill stress
test)
2. Prior evaluation by preventive cardiology
3. Active cardiac issues
4. Pregnancy, breastfeeding, or anticipating pregnancy in the next 2 years |
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| Study is available at: |
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Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St.
Pittsburgh, PA 15261
United States
Primary Contact:
Jennifer R Elliott, MD
Email: elliottjr@upmc.edu
Phone: 412-648-8708 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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