HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
Recruitment status was: Recruiting
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.
Heart Rate Variability Ischemia Detection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia|
- Positive percent agreement [ Time Frame: 1 year ] [ Designated as safety issue: No ]Positive percent agreement of ≥70% (with a lower confidence interval of 60%) between a positive HRV HeartTrends test and a positive ESE
- negative percent agreement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HeartTrends device testing is associated with a negative percent agreement of ≥70% with negative results detected by ESE.
≥10% difference between the positive percent agreement of HRV with ESE and the positive percent agreement of EST with ESE.
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02201017
|United States, Minnesota|
|Rochester, Minnesota, United States, MN 55905|
|Sheba medical center|
|Ramat Gan, Israel, 52621|
|Study Director:||Ilan Goldenberg, MD||THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS|