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
  Purpose

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.


Condition Intervention Phase
Psoriasis
Coronary Artery Disease
Procedure: CCTA Scan (Coronary CT Angiogram)
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Premature Coronary Artery Disease (CAD) in Severe Psoriasis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To establish the relationship between psoriasis and coronary disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893126

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Prachi P Agarwal, M.D. University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Prachi P Agarwal, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00893126     History of Changes
Other Study ID Numbers: HUM00020514
Study First Received: May 1, 2009
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
psoriasis
coronary arteriosclerosis
coronary events
rheumatoid arthritis
arthritis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Psoriasis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014