NCT01657006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

August 1, 2012

Last Update Submit

March 18, 2015

Conditions

Ischemic Heart Disease

Keywords

Heart rate variabilityischemic heart diseasemyocardial ischemia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for an exercise MPI.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (2)

  • Goldenberg I, Goldkorn R, Shlomo N, Einhorn M, Levitan J, Kuperstein R, Klempfner R, Johnson B. Heart Rate Variability for Risk Assessment of Myocardial Ischemia in Patients Without Known Coronary Artery Disease: The HRV-DETECT (Heart Rate Variability for the Detection of Myocardial Ischemia) Study. J Am Heart Assoc. 2019 Dec 17;8(24):e014540. doi: 10.1161/JAHA.119.014540. Epub 2019 Dec 16.

    PMID: 31838969DERIVED

  • Goldkorn R, Naimushin A, Shlomo N, Dan A, Oieru D, Moalem I, Rozen E, Gur I, Levitan J, Rosenmann D, Mogilewsky Y, Klempfner R, Goldenberg I. Comparison of the usefulness of heart rate variability versus exercise stress testing for the detection of myocardial ischemia in patients without known coronary artery disease. Am J Cardiol. 2015 Jun 1;115(11):1518-22. doi: 10.1016/j.amjcard.2015.02.054. Epub 2015 Mar 14.

    PMID: 25872904DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ilan Goldenberg, Prof.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 3, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

IL(1)