Ischemic Heart Disease Clinical Trial
Official title:
HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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