Clinical trial NCT01785511: Does Ultraviolet Irradiation Reduce Platelet Reactivity and Improve Coronary Microvascular Function in Man?
Official title: Does Ultraviolet Irradiation Reduce Platelet Reactivity and Improve Coronary Microvascular Function in Man?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
UV radiation
coronary flow reserve
nitric oxide
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Endothelium derived nitric oxide (NO) regulates vascular tone and blood pressure in man. NO also inhibits platelet aggregation and mediates a variety of beneficial anti-inflammatory and repair mechanisms. NO may also be a mediator in the release of the endogenous fibrinolytic factor, tissue-plasminogen activating factor (t-PA) from the endothelium.1 Via these actions it plays a very important role in protection of the vasculature from atherothrombosis and clinical sequelae such as myocardial infarction and stroke.

Visible and ultraviolet (UV) light relax vascular smooth muscles by producing NO in a phenomenon known as photorelaxation.2 The investigators have demonstrated significant stores of pre-formed, bound NO and other nitrosospecies in human skin, which are rapidly released upon exposure to UVA.3 The investigators have demonstrated recently that serum nitrite and nitroso-species are increased after standing in a UVA phototherapy cabinet and that local UVA exposure is associated with increased forearm arterial blood flow that is independent of skin temperature. The investigators have also demonstrated a fall in mean arterial blood pressure in subjects exposed UVA.

Cardiovascular morbidity and the prevalence of hypertension vary with latitude. The investigators hypothesise that some of this geographical variation may be explained by a diminished sunlight/UVA exposure with attendant negative effects upon NO bio-availability.4 To further examine the potential beneficial effects of UVA exposure we will examine the effects of whole-body UVA upon platelet activation and upon myocardial/coronary arterial flow reserve. The investigators will correlate these measures with systemic nitrate, nitrite and nitroso-species content in healthy volunteers.

HYPOTHESES

1. UVA irradiation enhances coronary flow reserve in healthy volunteers.
2. UVA irradiation suppresses platelet activation in healthy volunteers.
3. UVA irradiation enhances the release of endogenous fibrinolytic factors in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged between 18-45 years (inclusive).

Exclusion Criteria:

* Inability to provide informed consent
* Co-existent systemic disease (including any history of asthma, reactive airways disease or hypertension)
* Contraindication to UVA treatment
* Any history of cardiac conduction abnormality (including bundle branch block or atrial fibrillation)
* Smoker
* Current intake of aspirin, other non-steroid anti-inflammatory medications or any regular medication.
* Recent infective/inflammatory condition
* Echocardiographic evidence of left ventricular hypertrophy (left ventricular septal diameter \>1.2 cm in diastole), systolic dysfunction or significant valvular stenosis or regurgitation.

Primary outcomes:
measure: Coronary Flow Reserve
timeFrame: 0, 20, 40 and 60 mins
Secondary outcomes:
measure: Platelet Activation
timeFrame: 0, 20, 40 and 60 mins
measure: Endogenous Fibrinolysis
timeFrame: 0, 20, 40 and 60 minutes
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Lothian
Study officials:
affiliation: University of Edinburgh
name: Ninian Lang, MbChB
role: PRINCIPAL_INVESTIGATOR
References: