HeartTrends Heart Rate Variability (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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba Medical Center

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 21
Referral for exercise MPI by treating physicians
Willing and able to provide written informed consent

Exclusion criteria

Established ischemic heart disease
Atrial fibrillation or flutter
Acute Coronary Syndrome
Cardiac Pacemaker
Clinical diagnosis of heart failure
Moderate or severe COPD
Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
Any illness that might reduce life expectancy to less than 1 year from screening
Left bundle branch block (LBBB), significant intra-ventricular conduction delay (IVCD) or significant (>1mm) ST deviations on baseline ECG
Inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
Any significant established myocardial or valvular disease

Treatment and study plan

Primary outcomes

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")

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Aug 3, 2012
Registry last updated: Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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