NCT01899937

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

July 3, 2013

Last Update Submit

July 11, 2013

Conditions

Endothelial Dysfunction

Keywords

Endothelial dysfunctionFlow mediated dilationBrachial artery flow mediated dilationFMD

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow mediated dilation (FMD) analysis

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults - varied

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Pisa

Pisa, Italy

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Unilever R&D Vlaardingen

Vlaardingen, Netherlands

Location

Top Institute Food and Nutrition

Wageningen, Netherlands

Location

Study Officials

  • Lorenzo Ghiadoni

    University of Pisa

    PRINCIPAL INVESTIGATOR

  • Dick Thijssen

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 16, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

NL(3)IT(1)