Heart Rate Variability Ischemia DetectionNCT02201017
HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
An observational study of Heart Rate Variability Ischemia Detection, run by Sheba Medical Center at 2 sites in 2 countries.
Trial 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 pretest probability for CAD; 2) , or asymptomatic subjects with diabetes mellitus who are referred EST for risk… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Rate Variability Ischemia Detection
- How many people
- 621 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Acute Coronary Syndrome
- Established CAD
- Atrial fibrillation or flutter
- Cardiac Pacemaker
- Clinical diagnosis of heart failure
- Severe COPD (FEV1< 50% predicted value)
Show all 14Show fewer
- 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
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, MN 55905
Ilan Goldenberg, MD
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan, 52621
ilan Goldenberg, MD, Ilan.Goldenberg@sheba.health.gov.il
refael Koperstein, MD
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Rate Variability Ischemia DetectionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 621 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilan Goldenberg, MD, Study director, THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201017
- Sponsor's protocol ID
- SHEBA-14-1194-IG-CTIL
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31838969
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT02201017
- Acronym / sponsor ID
- SHEBA-14-1194-IG-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 621 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥ 21
- No known CAD
- Referral for EST due to either one of the following two indications:
- Willing and able to provide written informed consent
Key exclusion criteria (14 listed)
- Acute Coronary Syndrome
- Established CAD
- Atrial fibrillation or flutter
- Cardiac Pacemaker
- Clinical diagnosis of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive percent agreement
Time frame: 1 year
Positive percent agreement of ≥70% (with a lower confidence interval of 60%) between a positive HRV HeartTrends test and a positive ESE
1 secondary outcome
negative percent agreement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Derived from this study: PubMed 31838969Goldenberg 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Goldenberg, MD study director
THE ISRAELI ASSOCIATION FOR CARDIOVASCULAR TRIALS
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Variability Ischemia Detection, run by Sheba Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Goldenberg, prof (03-5344703, Ilan.Goldenberg@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive percent agreement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.