Premature Coronary Artery Disease (CAD) in Severe Psoriasis

October 18, 2016 updated by: Prachi P Agarwal, M.D., University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with severe psoriasis
Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan.
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 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.
Procedure: CCTA Scan (Coronary CT Angiogram)
CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To establish the relationship between psoriasis and coronary disease
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Prachi P Agarwal, M.D., University of Michigan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00020514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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