HeartTrends Heart Rate Variability (HRV) Algorithm for the Diagnosis of Myocardial Ischemia
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|ClinicalTrials.gov Identifier: NCT01657006|
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : March 19, 2015
The investigators intend to prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for routine exercise MPI at a tertiary care center.
Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a one-hour period of Holter ECG digital recording. Application of ECG electrodes will be performed by medical technicians following standard recommendations, utilizing approved Holter device & stickers. The Holter ECG data will be used for the offline heart rate variability (HRV) analysis by the HeartTrends device.
Immediately following data acquisition, all patients will undergo an exercise MPI according to accepted clinical practice guidelines.
Following the MPI, there will be no interference with patient management, which will be conducted by the patients' treating physicians according to current guidelines, unaware of HRV results.
Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results, by HeartTrends device.
The results of the HRV tests will not be available to treating physicians and will not be used to guide patient management. Patients will be followed for 6 months for the occurrence of coronary interventions and MACE, defined as: death, myocardial infarction, unstable angina, or any coronary revascularization.
|Condition or disease|
|Ischemic Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||450 participants|
|Official Title:||HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- Sensitivity of the HeartTrends device for the detection of myocardial ischemia [ Time Frame: 6 month ]sensitivity of the HeartTrends device in comparison to conventional exercise stress testing for the purpose of diagnosing significant myocardial ischemia based on exercise myocardial perfusion imaging examination (considered as the "gold standard")
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657006
|Sheba Medical Center|
|Ramat Gan, Israel|
|Principal Investigator:||Ilan Goldenberg, Prof.||Sheba Medical Center|