Heart Rate Variability Ischemia Detection Clinical Trial
Official title:
HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
A total of 621 consecutive male and female subjects, without established CAD, referred to
exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina
with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes
mellitus who are referred EST for risk assessment prior to initiation of an exercise
program.
To validate the diagnostic performance of the HeartTrends device for the detection and
ruling out of myocardial ischemia in a population of subjects who are currently referred for
cardiovascular evaluation using EST.
Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV
analysis by the HeartTrends device for the detection of myocardial ischemia, as determined
by stress echocardiography.
n/a
Observational Model: Cohort, Time Perspective: Prospective