Endothelial DysfunctionNCT01899937
Effect of Different Methodologies on Variability of Brachial Artery Flow Mediated Dilation
An observational study of Endothelial Dysfunction, run by Maastricht University Medical Center at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- How many people
- 15,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults - varied
Who may be able to join
- Observational cohorts and control groups of intervention studies with ≥ 50 subjects
Who cannot join
- ≤ 50 subjects
- Any co-intervention in control groups of intervention studies
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
Radboud University Nijmegen Medical Centre
Nijmegen
Unilever R&D Vlaardingen
Vlaardingen
Top Institute Food and Nutrition
Wageningen
About this study
Official title: Effect of Different Methodologies on Reliability of Flow Mediated Dilation as Measurement Tool: Meta-regression Analysis to Determine Minimum Quality Standards
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.
Read the 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.
- Conditions
- Endothelial Dysfunction
- Keywords
- Endothelial dysfunction, Flow mediated dilation, Brachial artery flow mediated dilation, FMD
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow mediated dilation (FMD) analysis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Principal investigator, Lian Engelen, Maastricht University Medical Center
- Investigators
- Lorenzo Ghiadoni, Principal investigator, University of PisaDick Thijssen, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899937
- Sponsor's protocol ID
- TIFN-CH001-IWG-FMD
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Methodologies on Reliability of Flow Mediated Dilation as Measurement Tool: Meta-regression Analysis to Determine Minimum Quality Standards
- ClinicalTrials.gov ID
- NCT01899937
- Acronym / sponsor ID
- TIFN-CH001-IWG-FMD
- Conditions
- Endothelial Dysfunction
- Keywords
- Endothelial dysfunction, Flow mediated dilation, Brachial artery flow mediated dilation, FMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults - varied
Key inclusion criteria (1 listed)
- Observational cohorts and control groups of intervention studies with ≥ 50 subjects
Key exclusion criteria (2 listed)
- ≤ 50 subjects
- Any co-intervention in control groups of intervention studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brachial artery flow mediated dilation (FMD) analysis
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
Related trials for Endothelial Dysfunction
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Ghiadoni principal investigator
University of Pisa
Dick Thijssen principal investigator
Radboud University Medical Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction, run by Maastricht University Medical Center at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow mediated dilation (FMD) analysis (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.