NCT00610805

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

January 24, 2008

Last Update Submit

January 14, 2016

Conditions

Systemic Lupus Erythematosus

Keywords

SLElupuscardiovascularIMTSystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

  • The efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque

    2 years

  • The effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals.

    2 years

Study Arms (2)

1

EXPERIMENTAL

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.

Other: Preventive Cardiology

2

OTHER

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.

Other: Usual Care

Interventions

Preventive CardiologyOTHER

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.

1
Usual CareOTHER

Participants will receive usual care per their primary care physician.

2

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Definitive diagnosis of SLE
  • \>18 years of age
  • Followed by rheumatologists (not the investigator, Dr. Elliott) at the Lupus Center of Excellence
  • Informed consent signed
  • Effective form of birth control

You may not qualify if:

  • Prior cardiovascular disease history (MI, coronary angioplasty, coronary artery bypass graft, abnormal coronary angiography, abnormal nuclear or treadmill stress test)
  • Prior evaluation by preventive cardiology
  • Active cardiac issues
  • Pregnancy, breastfeeding, or anticipating pregnancy in the next 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lupus Center of Excellence, Magee Womens Hospital, 300 Halket St, Suite 1750

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical and Translational Research Center (CTRC), Montefiore Hospital, 6NE, 200 Lothrop St.

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jennifer R Elliott, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 8, 2008

Study Start

November 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(2)