Endothelial Dysfunction Clinical Trial
— PUMEOfficial title:
Translational Research of Negative Emotions and Acute Endothelial Dysfunction
Verified date | January 2022 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study aims and hypotheses are as follows: Primary Hypotheses: Compared to the neutral condition, the anger recall task will acutely induce endothelial dysfunction by impairing endothelium-dependent arterial vasodilation (Hypothesis 1a); increasing circulating levels of EC-derived microparticles (EMPs), a marker of EC injury (Hypothesis 1b); and reducing circulating levels of bone marrow-derived endothelial progenitor cells (EPCs), a marker of EC reparative capacity (Hypothesis 1c). Secondary Hypotheses: Compared to the neutral condition, the depressed mood and separately the anxiety recall tasks will acutely impair endothelium-dependent arterial vasodilation, increase circulating levels of EMPs, and reduce circulating levels of bone marrow-derived EPCs. There will be a relation of the level of self-reported anger, depressed mood, and anxiety with endothelial dysfunction.
Status | Completed |
Enrollment | 280 |
Est. completion date | November 1, 2020 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 and over - Fluent in English Exclusion Criteria: - History of any chronic medical condition including prevalent CVD and traditional risk factors - Active smoking - Chronic medication use, including over-the-counter drugs or herbal medications - History of psychosis, a mood disorder, or any overt personality disorder - Latex allergy - Poor peripheral veins with low possibility of getting IV access |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Nitric oxide(NO) inhibition | Circulating measures of asymmetric dimethylarginine (ADMA) and oxidative stress measures | baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction | |
Other | Stress response | Circulating measures of catecholamines, cortisol, endothelin-1; blood pressure and heart rate | baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction | |
Primary | Endothelium-dependent arterial vasodilation | baseline | ||
Primary | Circulating EMPs expressing CD62E | baseline | ||
Primary | Circulating early EPCs (KDR+, CD34+, CD133+ cells) | baseline | ||
Primary | Endothelium-dependent arterial vasodilation | 3 mins after end of mood induction | ||
Primary | Endothelium-dependent arterial vasodilation | 40 mins after end of mood induction | ||
Primary | Endothelium-dependent arterial vasodilation | 70 mins after end of mood induction | ||
Primary | Endothelium-dependent arterial vasodilation | 100 mins after end of mood induction | ||
Primary | Circulating EMPs expressing CD62E | 3 mins after end of mood induction | ||
Primary | Circulating EMPs expressing CD62E | 40 mins after end of mood induction | ||
Primary | Circulating EMPs expressing CD62E | 70 mins after end of mood induction | ||
Primary | Circulating EMPs expressing CD62E | 100 mins after end of mood induction | ||
Primary | Circulating early EPCs (KDR+, CD34+, CD133+ cells) | 3 mins after end of mood induction | ||
Primary | Circulating early EPCs (KDR+, CD34+, CD133+ cells) | 40 mins after end of mood induction | ||
Primary | Circulating early EPCs (KDR+, CD34+, CD133+ cells) | 70 mins after end of mood induction | ||
Primary | Circulating early EPCs (KDR+, CD34+, CD133+ cells) | 100 mins after end of mood induction | ||
Secondary | Circulating EMPs expressing CD31 | baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction | ||
Secondary | Circulating EMPs expressing CD51 | baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction | ||
Secondary | Self-reported anger, depressed mood, and anxiety | baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction |
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