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Effect of Different Methodologies on Variability of Brachial Artery Flow Mediated Dilation

Primary Purpose

Endothelial Dysfunction

Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Endothelial Dysfunction focused on measuring Endothelial dysfunction, Flow mediated dilation, Brachial artery flow mediated dilation, FMD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Observational cohorts and control groups of intervention studies with ≥ 50 subjects

Exclusion Criteria:

  • ≤ 50 subjects
  • Any co-intervention in control groups of intervention studies

Sites / Locations

  • University of Pisa
  • Radboud University Nijmegen Medical Centre
  • Unilever R&D Vlaardingen
  • Top Institute Food and Nutrition

Outcomes

Primary Outcome Measures

Brachial artery flow mediated dilation (FMD) analysis

Secondary Outcome Measures

Full Information

First Posted
July 3, 2013
Last Updated
July 11, 2013
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01899937
Brief Title
Effect of Different Methodologies on Variability of Brachial Artery Flow Mediated Dilation
Official Title
Effect of Different Methodologies on Reliability of Flow Mediated Dilation as Measurement Tool: Meta-regression Analysis to Determine Minimum Quality Standards
Study Type
Observational

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Flow mediated dilation (FMD) of the brachial artery has been widely used as a non-invasive measure of endothelial function. FMD independently predicts future cardiovascular events and can be readily influenced by pharmacological, dietary or lifestyle interventions. However, the interpretation of FMD data is currently importantly hampered by differences in measurement methodologies and analysis techniques between laboratories. These differences result in large variation of 'normal' values between laboratories, highlighting the need for adopting widely supported and evidence-based guidelines.
Detailed Description
Background: Flow mediated dilation (FMD) of the brachial artery has been widely used as a non-invasive measure of endothelial function. FMD independently predicts future cardiovascular events and can be readily influenced by pharmacological, dietary or lifestyle interventions. Need for a review: Differences in methodology, guidelines (to control for moderating factors) and analysis techniques contribute to large variation in FMD between laboratories, limiting the widespread use and interpretation of FMD data. Objectives: To identify methodological and technological factors that contributes to the variability (i.e. repeatability) of the brachial artery FMD. This will allow for development of quality guidelines for FMD measurement based on systematic data analysis. Design: The planning and conduct of the proposed meta-analyses will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Data sources: MEDLINE, EMBASE Chemical Abstracts, Biosis and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Study selection: Observational cohorts and control groups of intervention studies with ≥ 50 subjects. Methods: A list of quality criteria for scoring of FMD data will be defined both by expert consensus and by thorough review of the literature. Subsequently, a database of brachial artery FMD data (from published data and available individual data) will be compiled. The investigators will investigate which of the quality criteria significantly contribute to the variability of FMD by multiple meta-regression analyses. This data set will also allow us to investigate which quality criteria have the strongest impact on the variability of the FMD, to further refine the list of quality criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction
Keywords
Endothelial dysfunction, Flow mediated dilation, Brachial artery flow mediated dilation, FMD

7. Study Design

Enrollment
15000 (Anticipated)
Primary Outcome Measure Information:
Title
Brachial artery flow mediated dilation (FMD) analysis
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Observational cohorts and control groups of intervention studies with ≥ 50 subjects Exclusion Criteria: ≤ 50 subjects Any co-intervention in control groups of intervention studies
Study Population Description
Adults - varied
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Ghiadoni
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dick Thijssen
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pisa
City
Pisa
Country
Italy
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
Country
Netherlands
Facility Name
Unilever R&D Vlaardingen
City
Vlaardingen
Country
Netherlands
Facility Name
Top Institute Food and Nutrition
City
Wageningen
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Effect of Different Methodologies on Variability of Brachial Artery Flow Mediated Dilation

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