Premature Coronary Artery Disease (CAD) in Severe Psoriasis

Coronary Artery Disease Clinical Trial

Official title:

Premature Coronary Artery Disease (CAD) in Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893126
• Other study ID #: HUM00020514
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2009
• Last updated: October 18, 2016
• Start date: November 2009
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Psoriasis

Intervention

Procedure:
• CCTA Scan (Coronary CT Angiogram)
CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the relationship between psoriasis and coronary disease		1 year	No