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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia
Study Start Date : August 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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")


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for an exercise MPI.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ilan Goldenberg, Prof. Sheba Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01657006     History of Changes
Other Study ID Numbers: SHEBA-12-9581-IG-CTIL
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Sheba Medical Center:
Heart rate variability
ischemic heart disease
myocardial ischemia

Additional relevant MeSH terms:
Heart Diseases
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases