Does Ultraviolet Irradiation Reduce Platelet Reactivity and Improve Coronary Microvascular Function in Man?

NCT01785511 | Completed DMC

• 1 other identifier: UVA Study
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

hypertension; UV radiation; coronary flow reserve; nitric oxide

Outcome Measures

Primary Outcomes (1)

• Coronary Flow Reserve

  Change in coronary flow assessed pre and post UVA radiation versus control

  0, 20, 40 and 60 mins

Secondary Outcomes (2)

• Platelet Activation

  0, 20, 40 and 60 mins

• Endogenous Fibrinolysis

  0, 20, 40 and 60 minutes

Study Arms (2)

Sham UVA

SHAM COMPARATOR

sham exposure will be provided by covering the UVA lamps with space blanket.

Radiation: UVA Radiation

UVA Radiation

EXPERIMENTAL

Patients will be exposed to UVA radiation for 20 minutes

Radiation: UVA Radiation

Interventions

UVA Radiation RADIATION

UVA radiation exposure for 20 minutes

Sham UVA; UVA Radiation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Lothian, Eh16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ninian Lang, MbChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: February 7, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

GB (1)