HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02201017
First received: July 16, 2014
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition
Heart Rate Variability Ischemia Detection

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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Positive percent agreement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Positive percent agreement of ≥70% (with a lower confidence interval of 60%) between a positive HRV HeartTrends test and a positive ESE


Secondary Outcome Measures:
  • negative percent agreement [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 621
Study Start Date: June 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (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

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.

Criteria

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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  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: NCT02201017

Contacts
Contact: Ilan Goldenberg, prof 03-5344703 Ilan.Goldenberg@sheba.health.gov.il

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, MN 55905
Contact: Ilan Goldenberg, MD         
Israel
Sheba medical center Recruiting
Ramat Gan, Israel, 52621
Contact: ilan Goldenberg, MD       Ilan.Goldenberg@sheba.health.gov.il   
Principal Investigator: refael Koperstein, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Ilan Goldenberg, MD THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02201017     History of Changes
Other Study ID Numbers: SHEBA-14-1194-IG-CTIL
Study First Received: July 16, 2014
Last Updated: July 23, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 15, 2014