A Multicenter Study Design to Assess the Clinical Usefulness of Semi-Automatic Measurement of Flow-Mediated Vasodilatation of the Brachial Artery

Abstract

SummaryFlow-mediated vasodilatation of the brachial artery (FMD) is a marker which is related to endothelial nitric oxide bioavailability. Commercially available ultrasound machines equipped with online computer-assisted semi-automatic analysis software to measure FMD have recently become available in Japan. These devices enable more convenient examination, enhanced reproducibility of FMD measurement, and a shortened examination time. Using such devices, in the present multicenter prospective study we propose to: 1) establish standardized FMD values and determine the annual rates of FMD change in healthy subjects; 2) confirm the predictive value of FMD for future cardiovascular events in Japanese subjects; 3) evaluate the potential usefulness of a multimarker strategy, including measurements of FMD, pulsewave velocity (PWV), ankle-brachial pressure index, biochemical markers, and proteomic biomarkers obtained by mass spectroscopic analysis to assess the prognosis of subjects with coronary artery disease; and 4) clarify the usefulness of FMD measurement to predict the rate of progression of carotid atherosclerosis, arterial stiffness and microalbuminuria in subjects with hypertension or diabetes mellitus. In total, we estimate that approximately 4000 Japanese subjects in 3 different study groups will eventually be enrolled in this prospective observational investigation. We anticipate that the present study will provide important evidence for the usefulness of FMD measurement in the risk stratification for cardiovascular disease. (Int Heart J 2012; 53: 170-175)

Endothelial Dysfunction, Increased Arterial Stiffness, and Cardiovascular Risk Prediction in Patients With Coronary Artery Disease: FMD‐J (Flow‐Mediated Dilation Japan) Study A

“…The rationale and design of FMD‐J Study A have been described previously 17. This study was a prospective multicenter observational cohort study conducted at 22 university hospitals and affiliated clinics in Japan to examine the usefulness of FMD assessment for the management of Japanese patients with CAD with a 3‐year follow‐up period 17.…”

“…This study was a prospective multicenter observational cohort study conducted at 22 university hospitals and affiliated clinics in Japan to examine the usefulness of FMD assessment for the management of Japanese patients with CAD with a 3‐year follow‐up period 17. The ethical committees of the participating institutions approved the study protocol.…”

“…Definitions of the clinical outcomes have been provided previously 17. All cardiovascular events were reported to the Efficacy Endpoint Review Committee annually from each institution.…”

“…Therefore, unfortunately, the usefulness of FMD and baPWV for risk stratification of patients with CAD has not been fully investigated. FMD‐J (Flow‐Mediated Dilation Japan) Study A was a prospective multicenter observational study designed to assess the predictive value of FMD for future cardiovascular events in patients with CAD independent of conventional cardiovascular risk factors and to evaluate the usefulness of a multimarker strategy to assess the prognosis of patients with CAD 17. The purpose of this multicenter study was to determine whether FMD, baPWV, and a combination of FMD and baPWV could be used as independent markers to predict the risk of recurrent cardiovascular events in patients with established CAD.…”

Pathophysiological Contribution of Vascular Function to Baroreflex Regulation in Hypertension

“…21 The subjects were instructed to fast for at least 6 h, and to abstain from alcohol, smoking, caffeine and antioxidant vitamins for at least 12 h prior to the measurements. They were asked to rest in the sitting position in a quiet, dark, air-conditioned room (24-26°C) for 5 min, and asked to rest again for at least 15 min in the supine position in the same room before the measurement of FMD.…”