HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia

A total of 621 consecutive male and female subjects, without established CAD, referred to exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk assessment prior to initiation of an exercise program.

To validate the diagnostic performance of the HeartTrends device for the detection and ruling out of myocardial ischemia in a population of subjects who are currently referred for cardiovascular evaluation using EST.

Prospective multicenter single-armed study, assessing the diagnostic accuracy of HRV analysis by the HeartTrends device for the detection of myocardial ischemia, as determined by stress echocardiography.

Study Overview

• Status: Unknown
• Conditions: Heart Rate Variability Ischemia Detection

• Study Type: Observational
• Enrollment (Anticipated): 621

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: ilan Goldenberg, MD; Email: Ilan.Goldenberg@sheba.health.gov.il
    • Principal Investigator: refael Koperstein, MD
• United States
  • Minnesota
    • Rochester, Minnesota, United States, MN 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Ilan Goldenberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 621 consecutive male and female subjects, without established CAD, referred to exercise stress testing (EST) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk assessment prior to initiation of an exercise program.

Pretest probability of CAD will be based on the ACC 2002 guideline update on exercise stress testing1.

Description

Inclusion Criteria:

• Age ≥ 21
• No known CAD

• Referral for EST due to either one of the following two indications:

  1. Chest pain syndrome or equivocal angina in subjects with intermediate pretest probability of CAD according to the 2002 updated guidelines for exercise stress examination.1 (See definition of intermediate pretest probability of CAD in Supplementary Appendix Table at the end of this document); or
  2. Asymptomatic subjects with diabetes mellitus referred to EST for risk assessment prior to initiation of an exercise program.
• Willing and able to provide written informed consent

Exclusion Criteria:

1. Acute Coronary Syndrome
2. Established CAD
3. Atrial fibrillation or flutter
4. Cardiac Pacemaker
5. Clinical diagnosis of heart failure
6. Severe COPD (FEV1< 50% predicted value)
7. Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
8. 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;
9. Any illness that might reduce life expectancy to less than 1 year from screening
10. Left bundle branch block (LBBB), significant intra-ventricular conduction delay (IVCD) or significant (>1mm) ST deviations on baseline ECG
11. Inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
12. Any significant valvular disease defined as:

Established valvular regurgitation or stenosis abnormality above moderate severity 13. BMI >35 kg/m2 14. Recent (< 6 months) history of pulmonary embolism

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive percent agreement	Positive percent agreement of ≥70% (with a lower confidence interval of 60%) between a positive HRV HeartTrends test and a positive ESE	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
negative percent agreement	HeartTrends device testing is associated with a negative percent agreement of ≥70% with negative results detected by ESE. ≥10% difference between the positive percent agreement of HRV with ESE and the positive percent agreement of EST with ESE.	1 year

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Study Director: Ilan Goldenberg, MD, THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: SHEBA-14-1194-IG-CTIL