Status:
UNKNOWN
HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
Lead Sponsor:
Sheba Medical Center
Conditions:
Heart Rate Variability Ischemia Detection
Eligibility:
All Genders
21+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 21
- No known CAD
- Referral for EST due to either one of the following two indications:
- 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
- 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
- Acute Coronary Syndrome
- Established CAD
- Atrial fibrillation or flutter
- Cardiac Pacemaker
- Clinical diagnosis of heart failure
- Severe COPD (FEV1\< 50% predicted value)
- 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 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
- \-
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2015
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT02201017
Start Date
June 1 2014
End Date
September 1 2015
Last Update
July 25 2014
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, MN 55905
2
Sheba medical center
Ramat Gan, Israel, 52621