Ischemic Heart Disease Clinical Trial
Official title:
HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia
Verified date | March 2015 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 450 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of the HeartTrends device for the detection of myocardial ischemia | 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") | 6 month | No |
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