Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriatic Disease Patients | Other | Moderate to severe psoriatic disease |
|
| Healthy Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin and/or Atorvastatin | Drug | This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Fold Change in Composite Endothelial Inflammation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Berger, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35490599 | Derived | Garshick MS, Block R, Drenkova K, Tawil M, James G, Brenna JT. Statin therapy upregulates arachidonic acid status via enhanced endogenous synthesis in patients with plaque psoriasis. Prostaglandins Leukot Essent Fatty Acids. 2022 May;180:102428. doi: 10.1016/j.plefa.2022.102428. Epub 2022 Apr 16. | |
| 32131611 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Psoriatic Disease Patients | Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation. |
| FG001 | Healthy Control | Healthy Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Psoriatic Disease Patients | Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation. |
| BG001 | Healthy Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Fold Change | Baseline, 5 Months |
|
2 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psoriatic Disease Patients | Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Garshick | NYU Langone | 212-263-0855 | michael.garshick@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2018 | Mar 5, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.
| Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin) |
| 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) |
| Garshick MS, Tawil M, Barrett TJ, Salud-Gnilo CM, Eppler M, Lee A, Scher JU, Neimann AL, Jelic S, Mehta NN, Fisher EA, Krueger JG, Berger JS. Activated Platelets Induce Endothelial Cell Inflammatory Response in Psoriasis via COX-1. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1340-1351. doi: 10.1161/ATVBAHA.119.314008. Epub 2020 Mar 5. |
| 30760013 | Derived | Garshick MS, Barrett TJ, Wechter T, Azarchi S, Scher JU, Neimann A, Katz S, Fuentes-Duculan J, Cannizzaro MV, Jelic S, Fisher EA, Krueger JG, Berger JS. Inflammasome Signaling and Impaired Vascular Health in Psoriasis. Arterioscler Thromb Vasc Biol. 2019 Apr;39(4):787-798. doi: 10.1161/ATVBAHA.118.312246. |
Healthy Control |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Fold Change Change in Composite Endothelial Inflammation | Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy | Posted | Mean | Full Range | Fold Change | 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. | Posted | Mean | Full Range | Fold Change | 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 | Posted | Median | Standard Deviation | ng/ml | Baseline (pre-Aspirin), 2 weeks (post-Aspirin) |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Healthy Control | Healthy Control | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
Not provided
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |