Ignite Creation Date:
2024-05-06 @ 3:07 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02201017
Status:
UNKNOWN
Last Update Posted:
2014-07-25
First Post:
2014-07-16
Brief Title:
HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 equivocalequivalent 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None