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Subclinical Cardiovascular Disease in Psoriatic Disease

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ClinicalTrials.gov Identifier: NCT03228017
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Myocardial Infarction Atherosclerotic Cardiovascular Disease Thrombotic Vascular Disease Drug: Aspirin and/or Atorvastatin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subclinical Cardiovascular Disease in Psoriatic Disease
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Psoriatic Disease Patients
Moderate to severe psoriatic disease
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.

No Intervention: Healthy Control



Primary Outcome Measures :
  1. Brachial artery reactivity [ Time Frame: 5 Months ]
    a measure of endothelial dysfunction as assessed through Nf-KB staining obtained through endothelial cell harvesting.


Secondary Outcome Measures :
  1. Baseline endothelial vein transcriptome data [ Time Frame: 5 Months ]
    Using paired t- tests will assess the changes in endothelial function with the use of aspirin, aspirin plus atorvastatin or atorvastatin therapy.

  2. Genetic expression for VCAM-1 [ Time Frame: 5 Months ]
    Untargeted RNA-sequencing will also be performed for untargeted analysis to identify novel markers of psoriatic disease and activity.

  3. Genetic expression for ICAM-1 [ Time Frame: 5 Months ]
    Untargeted RNA-sequencing will also be performed for untargeted analysis to identify novel markers of psoriatic disease and activity.

  4. Platelet reactivity with the use of aspirin [ Time Frame: 5 Months ]
    Platelet function assay that measures multiple platelet functions

  5. Endothelial function with the use of aspirin [ Time Frame: 5 Months ]
    Extrapolating this measurement with an n = 40 for psoriatic disease and n = 10 for controls gives us > 90% power to detect baseline endothelial function differences between groups with an alpha level of 0.05 (G*Power 3.1.9.2).

  6. Platelet reactivity with the use of aspirin plus atorvastatin [ Time Frame: 5 Months ]
    Platelet function assay that measures multiple platelet functions

  7. Endothelial function with the use of aspirin plus atorvastatin [ Time Frame: 5 Months ]
    Extrapolating this measurement with an n = 40 for psoriatic disease and n = 10 for controls gives us > 90% power to detect baseline endothelial function differences between groups with an alpha level of 0.05 (G*Power 3.1.9.2).

  8. Platelet reactivity with the use of atorvastatin therapy. [ Time Frame: 5 Months ]
    Platelet function assay that measures multiple platelet functions

  9. Endothelial function with the use of atorvastatin therapy. [ Time Frame: 5 Months ]
    Extrapolating this measurement with an n = 40 for psoriatic disease and n = 10 for controls gives us > 90% power to detect baseline endothelial function differences between groups with an alpha level of 0.05 (G*Power 3.1.9.2).



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228017


Contacts
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Contact: Michael Garshick 212 263 4004 micahel.garshick@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Michael Garshick    212-263-4004    Michael.Garshick@nyumc.org   
Principal Investigator: Jeffrey Berger, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jeffrey Berger, MD NYU Langone Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03228017     History of Changes
Other Study ID Numbers: 17-00692
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
cardiovascular disease
CVD
Additional relevant MeSH terms:
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Myocardial Infarction
Vascular Diseases
Atherosclerosis
Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Atorvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents