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OpenTrials
Completed

NCT Number: NCT00893126

Premature Coronary Artery Disease (CAD) in Severe Psoriasis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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:
  • 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

Treatment and study plan

CCTA Scan (Coronary CT Angiogram)

Procedure

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

Primary outcomes

  1. To establish the relationship between psoriasis and coronary disease

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
May 5, 2009
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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