Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Myocardial Infarction, Thrombotic Vascular Disease
Conditions
Keywords
cardiovascular disease, CVD
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.
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.
Interventions
DRUGAspirin and/or Atorvastatin
This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript | Baseline, 5 Months | Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fold Change Change in Composite Endothelial Inflammation | Baseline (pre-Aspirin), 2 weeks (post-Aspirin) | Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy |
| Fold Change in Composite Endothelial Inflammation | Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin) | Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy. |
| Change in Levels of Circulating Thromboxane B2 | Baseline (pre-Aspirin), 2 weeks (post-Aspirin) | Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Healthy Control Healthy Control | 18 |
| Total | 63 |
Baseline characteristics
| Characteristic | Psoriatic Disease Patients | Total | Healthy Control |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 14.2 | 42.75 years STANDARD_DEVIATION 13.5 | 40.5 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 53 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 37 Participants | 49 Participants | 12 Participants |
| Region of Enrollment United States | 45 participants | 63 participants | 18 participants |
| Sex: Female, Male Female | 23 Participants | 31 Participants | 8 Participants |
| Sex: Female, Male Male | 22 Participants | 32 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 18 |
| other Total, other adverse events | 0 / 45 | 0 / 18 |
| serious Total, serious adverse events | 0 / 45 | 0 / 18 |
Outcome results
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
Time frame: Baseline, 5 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriatic Disease Patients | Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript | 8.6 Fold Change | Standard Deviation 8.6 |
| Healthy Control | Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript | 2.8 Fold Change | Standard Deviation 2.2 |
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
Time frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Psoriatic Disease Patients | Change in Levels of Circulating Thromboxane B2 | 1 ng/ml | Standard Deviation 0.8 |
| Healthy Control | Change in Levels of Circulating Thromboxane B2 | 4.05 ng/ml | Standard Deviation 3 |
Secondary
Fold Change Change in Composite Endothelial Inflammation
Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy
Time frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Psoriatic Disease Patients | Fold Change Change in Composite Endothelial Inflammation | -0.28 Fold Change |
| Healthy Control | Fold Change Change in Composite Endothelial Inflammation | -0.04 Fold Change |
Secondary
Fold Change in Composite Endothelial Inflammation
Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.
Time frame: Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Psoriatic Disease Patients | Fold Change in Composite Endothelial Inflammation | -0.1 Fold Change |
| Healthy Control | Fold Change in Composite Endothelial Inflammation | 0.1 Fold Change |