HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2014 |
| End Date: | September 2015 |
| Contact: | Ilan Goldenberg, prof |
| Email: | Ilan.Goldenberg@sheba.health.gov.il |
| Phone: | 03-5344703 |
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.
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.
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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