Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Arthritis Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00610805
First received: January 24, 2008
Last updated: October 3, 2008
Last verified: October 2008

January 24, 2008
October 3, 2008
November 2009
November 2011   (final data collection date for primary outcome measure)
  • The efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610805 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cardiology Prevention in Systemic Lupus Erythematosus (SLE)
Cardiology Prevention Trial in Systemic Lupus Erythematosus

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Systemic Lupus Erythematosus
  • Other: Preventive Cardiology
    Patients will receive those interventions recommended by the Preventive Cardiologist. This may include: exercise, electrocardiogram, specialized blood testing, blood pressure monitoring, nutrition counseling, smoking cessation counseling, and pharmacotherapy for hypercholesterolemia, hypertension, and blood sugar abnormalities.
  • Other: Usual Care
    Participants will receive usual care per their primary care physician.
  • Experimental: 1
    Participants randomized to this arm (n=15) will be followed by Preventive Cardiology and will have appropriate goal oriented interventions on their risk factor levels for 2 years.
    Intervention: Other: Preventive Cardiology
  • 2
    Participants randomized to this arm (n=15) will receive usual care. The PI will send a letter of all testing results to their primary care physician. No standard care will be withheld.
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Female
19 Years and older
No
Contact: Jennifer R Elliott, MD 412-648-8708 elliottjr@upmc.edu
Contact: Linda Santelices, MS 412-641-7637 slinda@pitt.edu
United States
 
NCT00610805
PRO07050181
Yes
Jennifer Elliott, MD, University of Pittsburgh
University of Pittsburgh
  • Arthritis Foundation
  • National Institutes of Health (NIH)
Principal Investigator: Jennifer R Elliott, MD University of Pittsburgh
University of Pittsburgh
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP