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

• Conditions: Endothelial Dysfunction

• Registration Number: NCT01899937
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-11
• Last Update Submitted: 2013-07-11
• Study First Posted: 2013-07-16
• Last Update Posted: 2013-07-16
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brachial artery flow mediated dilation (FMD) analysis	10 years

Trial Locations

Locations (4)

University of Pisa; 🇮🇹 Pisa, Italy

Top Institute Food and Nutrition; 🇳🇱 Wageningen, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Unilever R&D Vlaardingen; 🇳🇱 Vlaardingen, Netherlands