Premature Coronary Artery Disease (CAD) in Severe Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prachi P Agarwal, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00893126
First received: May 1, 2009
Last updated: May 30, 2014
Last verified: May 2014

May 1, 2009
May 30, 2014
November 2009
October 2014   (final data collection date for primary outcome measure)
To establish the relationship between psoriasis and coronary disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00893126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Premature Coronary Artery Disease (CAD) in Severe Psoriasis
Premature Coronary Artery Disease (CAD) in Severe Psoriasis

The purpose of this study is to compare the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors.

To establish the relationship between psoriasis and coronary disease by comparing the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors, as determined by CT coronary calcium scoring and Coronary CT angiography.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Subjects with severe psoriasis will be selected prospectively from the clinics of the University of Michigan, Dept. of Dermatology.

The comparison group (subjects without psoriasis) will be targeted in the Dermatology clinic by screening for matching variables before enrollment. This group will be matched by age and gender to the psoriasis population, and on Framingham risk score.

  • Psoriasis
  • Coronary Artery Disease
Procedure: CCTA Scan (Coronary CT Angiogram)
CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).
  • Subjects with severe psoriasis
    Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan.
    Intervention: Procedure: CCTA Scan (Coronary CT Angiogram)
  • Subjects without psoriasis
    Subjects 18 to 55 who do not have psoriasis or rheumatologic conditions, including rheumatoid arthritis and systemic lupus erythematosus. This group of subjects will complete a CCTA (Coronary CT Angiogram)scan.
    Intervention: Procedure: CCTA Scan (Coronary CT Angiogram)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
October 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with severe psoriasis as determined by more than two episodes of systemic or inpatient treatment and 10% or more body surface area involvement.
  2. Male or female ages 18 to 55 (because CAD risk has been shown to be greatest in younger psoriasis patients in earlier studies, this pilot study will focus on young individuals).
  3. Able to give informed consent

Exclusion Criteria:

  1. Prior diagnosis of CAD (coronary artery disease) or heart disease based upon one or more of the following:

    • coronary arteriography
    • percutaneous coronary intervention
    • cardiac surgery including bypass graft surgery
    • valve surgery
    • congenital heart disease repair
    • stress ECG or imaging
    • myocardial infarction
    • angina or unstable angina
    • congestive heart failure
    • cardiomyopathy
  2. History of anti-oxidants such as fish oil or biologic therapy Tumor Necrosis Factor alpha inhibitors (such as etanercept, adalimumab, or infliximab). A recent review by Sattar et al [22] has shown preliminary evidence that TNF (tumor necrosis factor) blockade can modulate nontraditional cardiovascular risk factors such as C-reactive protein(CRP), Interleukin-6(IL-6), Apolipoprotein AI(ApoAI), Lipoprotein(a)(Lp[a]), Sex Hormone Binding Globulin (SHBG), and homocysteine to exert a possible vascular and metabolic protective effect.
  3. Pustular and erythrogenic psoriasis
  4. Unable to give informed consent
  5. Contraindications to coronary CT, including:

    • Irregular heart rate, such as multiple PVCs (premature ventricular contractions), atrial fibrillation
    • Active heart failure
    • Serum creatinine > 1.5mg/dl
    • Weight > 320 lbs (due to degradation in CT (computerized tomography)image quality by image noise)
    • History of severe allergy to intravenous contrast media
    • High irregular heart rate with contraindications to beta-blockers
    • Pregnant
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00893126
HUM00020514
No
Prachi P Agarwal, M.D., University of Michigan
University of Michigan
Not Provided
Principal Investigator: Prachi P Agarwal, M.D. University of Michigan Hospital
University of Michigan
May 2014

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