NCT02201017

HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 621 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Rate Variability Ischemia Detection

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2014-07-25
• Last updated: 2014-07-25

Locations

2 sites across 2 countries: United States, Israel