Microvascular Function Assessment in Healthy Subjects | NCT01572961

Studies
Microvascular Function Assessment in Healthy Subjects

NCT01572961

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Feb 12, 2016Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Physiology of Microvascular Skin

Interventions

acetylsalicilic acids (Aspirin)
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Mar 2012Actual

Completion Date

May 2013Actual

First Submitted Date

Apr 4, 2012

First Submission Date that Met QC Criteria

Apr 5, 2012

First Posted Date

Apr 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2016

Last Update Posted Date

Feb 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspirin	Active Comparator	Aspirin	Drug: acetylsalicilic acids (Aspirin)
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acetylsalicilic acids (Aspirin)	Drug	single oral dose of 1g.	Aspirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The increase of Laser Doppler Blood Flow after the second current stimulation		1 hour

Secondary Outcomes

Measure	Description	Time Frame
The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > or equal to 18 years old
Healthy subjects

Exclusion Criteria:

Aspirin allergy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume Mahe, M.D., Ph.D.	University hospital of Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Angers	Maine et Loire	49933	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25753207	Derived	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.

ID	Term
D001241	Aspirin
C010395	acetylsalicylic acid lysinate

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives