Microvascular Function Assessment in Healthy Subjects

NCT ID: NCT01572961

Last Updated: 2016-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-05-31

Brief Summary

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Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.

Detailed Description

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Conditions

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Physiology of Microvascular Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aspirin

Aspirin

Group Type ACTIVE_COMPARATOR

acetylsalicilic acids (Aspirin)

Intervention Type DRUG

single oral dose of 1g.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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acetylsalicilic acids (Aspirin)

single oral dose of 1g.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Aspegic 1000mg, sanofi aventis.

Eligibility Criteria

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Inclusion Criteria

* Age \> or equal to 18 years old
* Healthy subjects

Exclusion Criteria

* Aspirin allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Mahe, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University hospital of Angers

Locations

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University Hospital

Angers, Maine et Loire, France

Site Status

Countries

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France

References

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Mahe G, Abraham P, Humeau-Heurtier A, Gascoin L, Leftheriotis G, Durand S. Evidence for a vasomotor cyclo-oxygenase dependent mechanism of sensitization at the cutaneous level. Br J Clin Pharmacol. 2015 Aug;80(2):185-92. doi: 10.1111/bcp.12623. Epub 2015 May 26.

Reference Type DERIVED
PMID: 25753207 (View on PubMed)

Other Identifiers

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2010-10

Identifier Type: -

Identifier Source: org_study_id

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