Premature Coronary Artery Disease (CAD) in Severe Psoriasis

NCT00893126 | Completed

• 1 other identifier: HUM00020514
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis; Coronary Artery Disease

Keywords

psoriasis; coronary arteriosclerosis; coronary events; rheumatoid arthritis; arthritis

Outcome Measures

Primary Outcomes (1)

• To establish the relationship between psoriasis and coronary disease

  1 year

Study Arms (2)

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)

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)

Interventions

CCTA Scan (Coronary CT Angiogram) PROCEDURE

CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).

Subjects with severe psoriasis; Subjects without psoriasis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patients with severe psoriasis as determined by more than two episodes of systemic or inpatient treatment and 10% or more body surface area involvement.
• 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).
• Able to give informed consent

You may not qualify if:

• 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
• 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.
• Pustular and erythrogenic psoriasis
• Unable to give informed consent
• Contraindications to coronary CT, including:

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

31 ml of blood will be drawn in conjunction with this study.Lipid, Glucose and Lipoprotein will be drawn in one SST tube = 7 ml. Insulin (INS) will be collected in one Green top tube = 7 ml. HSCRP- will be collected in on SSS tube = 7 ml. IL-6 will be collected in Red or Lavender top tube = 7 ml. An additional 3 ml will be drawn for ICAM testing. (The blood for the ICAM testing and IL- 6 will be drawn and frozen until funding has been obtained to run these tests). Specimens will be be properly disposed of after testing is completed.

MeSH Terms

Conditions

Psoriasis; Coronary Artery Disease; Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Prachi P Agarwal, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 5, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)