Premature Coronary Artery Disease (CAD) in Severe Psoriasis

Completed

• Conditions: Psoriasis; Coronary Artery Disease
• Interventions: Procedure: CCTA Scan (Coronary CT Angiogram)

• Registration Number: NCT00893126
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-05
• Study Start: 2009-11
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with severe psoriasis	CCTA Scan (Coronary CT Angiogram)	Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan.
Subjects without psoriasis	CCTA Scan (Coronary CT Angiogram)	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.

Primary Outcome Measures

Name	Time	Method
To establish the relationship between psoriasis and coronary disease	1 year

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States