Clinical trial NCT01899937: 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
Overall status: UNKNOWN
Conditions: Endothelial Dysfunction
Keywords: Endothelial dysfunction
Flow mediated dilation
Brachial artery flow mediated dilation
FMD
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2013-07-16
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Adults - varied

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.

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

Primary outcomes:
measure: Brachial artery flow mediated dilation (FMD) analysis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Vlaardingen
country: Netherlands
facility: Unilever R&D Vlaardingen
city: Wageningen
country: Netherlands
facility: Top Institute Food and Nutrition
Study officials:
affiliation: University of Pisa
name: Lorenzo Ghiadoni
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Dick Thijssen
role: PRINCIPAL_INVESTIGATOR
References: