HeartTrends Heart Rate Variability (HRV) Algorithm for the Diagnosis of Myocardial Ischemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01657006
First received: August 1, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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
Ischemic Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Sensitivity of the HeartTrends device for the detection of myocardial ischemia [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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")


Estimated Enrollment: 283
Study Start Date: August 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657006

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Ilan Goldenberg, Prof.       Ilan.Goldenberg@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ilan Goldenberg, Prof. Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01657006     History of Changes
Other Study ID Numbers: SHEBA-12-9581-IG-CTIL
Study First Received: August 1, 2012
Last Updated: May 8, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 29, 2014