Mainz Registry of Flow-mediated Constriction

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Tommaso Gori, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01787370
First received: February 6, 2013
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Mainz Registry of Flow-mediated Constriction

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Endothelial function [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 1000
Study Start Date: September 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing coronary angiography
Consecutive patients referred for coronary angiography for the suspect of coronary artery disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787370

Contacts
Contact: Tommaso Gori, MD PhD +49 6131 172829 tommaso.gori@unimedizin-mainz.de

Locations
Germany
University Medical Center Mainz Recruiting
Mainz, Rheinland Pfalz, Germany, 55131
Contact: Tommaso Gori, MD PhD    +496131172829    tommaso.gori@unimedizin-mainz.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Tommaso Gori, MD PhD Universitätsmedizin Mainz
  More Information

Publications:
Responsible Party: Tommaso Gori, Prof., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01787370     History of Changes
Other Study ID Numbers: Flow-MEC
Study First Received: February 6, 2013
Last Updated: March 16, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
coronary artery disease, endothelial dysfunction

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014