Mainz Registry of Flow-mediated Constriction

February 27, 2018 updated by: Tommaso Gori, Johannes Gutenberg University Mainz
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Coronary artery disease (CAD) is a lifelong process resulting from the interaction of many risk factors, environmental influences, and genetic predisposition. Although the collection of medical history and standard risk factors provides essential information, the existence of complex interactions among different risk factors, risk modifications by medical therapy, and inter-individual differences complicate these issues. In the light of these limitations, alternative approaches have been sought, and the non-invasive assessment of endothelial function has been proposed as a possible non-invasive and inexpensive endpoint that could reflect the cumulative cardiovascular burden and/or the responsiveness to therapies at the level of individual patients.

A total of 1000 consecutive patients undergoing elective coronary angiography will be studied. Patients have chest pain on effort according to the American College of Cardiology/American Heart Association 2007 Guidelines and/or a pathological exercise or dobutamine stress test. 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.) will be excluded. Patients with known chronic inflammatory diseases, dialysis, or decompensated/severe heart failure will be also excluded.

Blood samples will be drawn from all patients after a fasting period of at least 12 h and will be examined with the use of routine laboratory methods for blood counts, lipid parameters, C-reactive protein, renal and hepatic function. Coronary risk factors were defined as: obesity (body mass index >30 kg/m2); age; smoking (or previous smoking); hyperlipidaemia (total serum cholesterol >220 mg/dL and/or serum triglycerides >200 mg/dL); hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg on two consecutive seated measurements or therapy with antihypertensive medication); family history (first-degree relatives with cardiovascular disease); diabetes mellitus (fasting serum glucose levels >126 mg/dL or therapy with oral hypoglycaemic agents or insulin).

The methods employed for L-FMC/FMD (flow mediated dilation)'analysis in our laboratory have been previously published (Gori Journal of the American College of Cardiology 2008). Briefly, patients will be placed supine, the left arm immobilized, and L-FMC and FMD will be measured using a Vivid 7 (General Electrics, Munich, Germany) ultrasound platform equipped with a 14 MHz matrix probe and a micrometric probe holder. Low-flow-mediated constriction corresponds to the constriction observed during a 4.5 min occlusion of a pneumatic cuff placed distal to the site of arterial diameter measurement. Flow-mediated dilation corresponds to the maximal dilation observed in the 5 min following deflation of the cuff, i.e. during reactive hyperaemia. Repeatability and reproducibility data of these methods have been recently reported (intra-class correlation coefficient=0.68 and 0.80 for FMD and L-FMC, respectively).

All data will be acquired digitally and analysed in a randomized, blinded fashion prior to coronary angiography by an investigator not aware of the clinical status of the patient, using automatic dedicated software.

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany, 55131
        • University Medical Center Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing coronary angiography for the suspect of coronary artery disease.

Description

Inclusion Criteria:

  • age >18 years
  • capacity to provide informed consent

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients undergoing coronary angiography
Consecutive patients referred for coronary angiography for the suspect of coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: Baseline
Flow-mediated dilation (change in diameter of the radial artery in response to increases in shear stress) will be measured at entry in the registry
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Tommaso Gori, MD PhD, Universitätsmedizin Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 24, 2018

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flow-MEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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