Subclinical Cardiovascular Disease in Psoriatic Disease

Cardiovascular Diseases Clinical Trial

Official title:

Subclinical Cardiovascular Disease in Psoriatic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228017
• Other study ID #: 17-00692
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.

Description:

Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects with a history of moderate to severe psoriatic disease

• Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease

Exclusion Criteria:

• Unable to speak Spanish or English

• Active smoking (within the past year)

• Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis

• Known active cancer receiving treatment

• Pregnancy

• Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)

• A history of severe bleeding or bleeding disorders

• Current medication use which interact with either aspirin or atorvastatin

• Chronic kidney disease (CrCl < 30ml/min)

• Congestive heart failure

• Currently taking aspirin or a statin.

• NSAID use within the past 48 hours

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Thrombotic Vascular Disease
• Vascular Diseases

Intervention

Drug:
• Aspirin and/or Atorvastatin
This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript	Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation	Baseline, 5 Months
Secondary	Fold Change Change in Composite Endothelial Inflammation	Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy	Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Secondary	Fold Change in Composite Endothelial Inflammation	Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.	Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
Secondary	Change in Levels of Circulating Thromboxane B2	Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy	Baseline (pre-Aspirin), 2 weeks (post-Aspirin)