Microvascular Function Assessment in Healthy Subjects (MICROTEC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01572961
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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 Intervention
Physiology of Microvascular Skin
Drug: acetylsalicilic acids (Aspirin)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • The increase of Laser Doppler Blood Flow after the second current stimulation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: November 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin Drug: acetylsalicilic acids (Aspirin)
single oral dose of 1g.
Other Name: Aspegic 1000mg, sanofi aventis.
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Aspirin allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572961

Locations
France
University Hospital Recruiting
Angers, Maine et Loire, France, 49933
Contact: Guillaume MAHE, M.D.,Ph.D.       gumahe@chu-angers.fr   
Principal Investigator: Guillaume MAHE, M.D.,Ph.D.         
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Guillaume Mahe, M.D., Ph.D. University hospital of Angers
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01572961     History of Changes
Other Study ID Numbers: 2010-10
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: France: Ministry of Health

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014