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Microvascular Function Assessment in Healthy Subjects (MICROTEC)

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ClinicalTrials.gov Identifier: NCT01572961
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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.

Condition or disease Intervention/treatment Phase
Physiology of Microvascular Skin Drug: acetylsalicilic acids (Aspirin) Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains
Study Start Date : November 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin
Aspirin
Drug: acetylsalicilic acids (Aspirin)
single oral dose of 1g.
Other Name: Aspegic 1000mg, sanofi aventis.

Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. The increase of Laser Doppler Blood Flow after the second current stimulation [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration [ Time Frame: 1 hour ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > or equal to 18 years old
  • Healthy subjects

Exclusion Criteria:

  • Aspirin allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572961


Locations
France
University Hospital
Angers, Maine et Loire, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Guillaume Mahe, M.D., Ph.D. University hospital of Angers

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01572961     History of Changes
Other Study ID Numbers: 2010-10
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by University Hospital, Angers:
Laser Doppler flowmetry, skin, microcirculation

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics