Premature Coronary Artery Disease (CAD) in Severe Psoriasis

NCT ID: NCT00893126

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Psoriasis; Coronary Artery Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with severe psoriasis

Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan.

CCTA Scan (Coronary CT Angiogram)

Intervention Type: PROCEDURE

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.

CCTA Scan (Coronary CT Angiogram)

Intervention Type: PROCEDURE

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

Interventions

CCTA Scan (Coronary CT Angiogram)

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Prachi P Agarwal, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prachi P Agarwal, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00020514

Identifier Type: -

Identifier Source: org_study_id