Mainz Registry of Flow-mediated Constriction
1 other identifier
observational
750
1 country
1
Brief Summary
The goal of the flow-mediated constriction/ FMC-registry is to investigate whether the measurement of endothelial function using flow-mediated dilation and flow-mediated constriction provides on the presence of coronary atherosclerosis and on the prognosis of patients undergoing coronary angiography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Longer than P75 for all trials
1 active site
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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2018
CompletedFebruary 28, 2018
February 1, 2018
8.4 years
February 6, 2013
February 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial function
Flow-mediated constriction (change in diameter of the radial artery induced by a reduction in local shear stress) will be measured at entry in the registry
Baseline
Secondary Outcomes (1)
Endothelial function
Baseline
Study Arms (1)
Patients undergoing coronary angiography
Consecutive patients referred for coronary angiography for the suspect of coronary artery disease
Eligibility Criteria
Consecutive patients undergoing coronary angiography for the suspect of coronary artery disease.
You may qualify if:
- age \>18 years
- capacity to provide informed consent
You may not qualify if:
- Patients undergoing catheterization for any reason other than stable (suspected) CAD (e.g. for hypertensive crisis associated with troponin elevation, or acute coronary syndromes, valvular heart disease, congenital heart disease, cardiomyopathy, etc.).
- Patients with known chronic inflammatory diseases, dialysis, or decompensated/severe heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Related Publications (1)
Gori T, Muxel S, Damaske A, Radmacher MC, Fasola F, Schaefer S, Schulz A, Jabs A, Parker JD, Munzel T. Endothelial function assessment: flow-mediated dilation and constriction provide different and complementary information on the presence of coronary artery disease. Eur Heart J. 2012 Feb;33(3):363-71. doi: 10.1093/eurheartj/ehr361. Epub 2011 Sep 14.
PMID: 21920964RESULT
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tommaso Gori, MD PhD
Universitätsmedizin Mainz
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 8, 2013
Study Start
September 1, 2009
Primary Completion
February 1, 2018
Study Completion
February 24, 2018
Last Updated
February 28, 2018
Record last verified: 2018-02