Ischemic Heart DiseaseNCT01657006
HeartTrends Heart Rate Variability (HRV) Algorithm for the Diagnosis of Myocardial Ischemia
An observational study of Ischemic Heart Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The investigators intend to prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for routine exercise MPI at a tertiary care center. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 450 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Jun 2014
- 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: The study will prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for an exercise MPI.
Who may be able to join
- Age ≥ 21
- Referral for exercise MPI by treating physicians
- Willing and able to provide written informed consent
Who cannot join
- Established ischemic heart disease
- Atrial fibrillation or flutter
- Acute Coronary Syndrome
- Cardiac Pacemaker
- Clinical diagnosis of heart failure
- Moderate or severe COPD
Show all 12Show 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 established myocardial or valvular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia
The investigators intend to prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for routine exercise MPI at a tertiary care center.
Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a one-hour period of Holter ECG digital recording. Application of ECG electrodes will be performed by medical technicians following standard recommendations, utilizing approved Holter device \& stickers. The Holter ECG data will be used for the offline heart rate variability (HRV) analysis by the HeartTrends device.
Read more
Immediately following data acquisition, all patients will undergo an exercise MPI according to accepted clinical practice guidelines.
Following the MPI, there will be no interference with patient management, which will be conducted by the patients' treating physicians according to current guidelines, unaware of HRV results.
Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results, by HeartTrends device.
The results of the HRV tests will not be available to treating physicians and will not be used to guide patient management. Patients will be followed for 6 months for the occurrence of coronary interventions and MACE, defined as: death, myocardial infarction, unstable angina, or any coronary revascularization.
- Conditions
- Ischemic Heart Disease
- Keywords
- Heart rate variability, ischemic heart disease, myocardial ischemia
- Medical subject headings
- Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the HeartTrends device for the detection of myocardial ischemia
sensitivity of the HeartTrends device in comparison to conventional exercise stress testing for the purpose of diagnosing significant myocardial ischemia based on exercise myocardial perfusion imaging examination (considered as the "gold standard")
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilan Goldenberg, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657006
- Sponsor's protocol ID
- SHEBA-12-9581-IG-CTIL
- Status last verified
- Mar 2015
- First submitted
- 1 Aug 2012
- Last updated
- 19 Mar 2015
- 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 31838969Goldkorn R, Naimushin A, Shlomo N, Dan A, Oieru D, Moalem I, Rozen E, Gur I, Levitan J, Rosenmann D, Mogilewsky Y, Klempfner R, Goldenberg I. Comparison of the usefulness of heart rate variability versus exercise stress testing for the detection of myocardial ischemia in patients without known coronary artery disease. Am J Cardiol. 2015 Jun 1;115(11):1518-22. doi: 10.1016/j.amjcard.2015.02.054. Epub 2015 Mar 14.
PubMed 25872904
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartTrends HRV Algorithm for the Diagnosis of Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT01657006
- Acronym / sponsor ID
- SHEBA-12-9581-IG-CTIL
- Conditions
- Ischemic Heart Disease
- Keywords
- Heart rate variability, ischemic heart disease, myocardial ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Aug 2012 (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.
The investigators intend to prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for routine exercise MPI at a tertiary care center.
Prior to the MPI (nuclear stress test), eligible and consenting patients will undergo a one-hour period of Holter ECG digital recording. Application of ECG electrodes will be performed by medical technicians following standard recommendations, utilizing approved Holter device \& stickers. The Holter ECG data will be used for the offline heart rate variability (HRV) analysis by the HeartTrends device.
Immediately following data acquisition, all patients will undergo an exercise MPI according to accepted clinical practice guidelines.
Following the MPI, there will be no interference with patient management, which will be conducted by the patients' treating physicians according to current guidelines, unaware of HRV results.
Analysis of recorded ECG data for HRV will be performed blinded to the EST and MPI results, by HeartTrends device.
The results of the HRV tests will not be available to treating physicians and will not be used to guide patient management. Patients will be followed for 6 months for the occurrence of coronary interventions and MACE, defined as: death, myocardial infarction, unstable angina, or any coronary revascularization.
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
- The study will prospectively enroll consecutive patients, without known ischemic heart disease, referred by their physician for an exercise MPI.
Key inclusion criteria (3 listed)
- Age ≥ 21
- Referral for exercise MPI by treating physicians
- Willing and able to provide written informed consent
Key exclusion criteria (12 listed)
- Established ischemic heart disease
- Atrial fibrillation or flutter
- Acute Coronary Syndrome
- 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
Sensitivity of the HeartTrends device for the detection of myocardial ischemia
Time frame: 6 month
sensitivity of the HeartTrends device in comparison to conventional exercise stress testing for the purpose of diagnosing significant myocardial ischemia based on exercise myocardial perfusion imaging examination (considered as the "gold standard")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- 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.
- Derived from this study: PubMed 25872904Goldkorn R, Naimushin A, Shlomo N, Dan A, Oieru D, Moalem I, Rozen E, Gur I, Levitan J, Rosenmann D, Mogilewsky Y, Klempfner R, Goldenberg I. Comparison of the usefulness of heart rate variability versus exercise stress testing for the detection of myocardial ischemia in patients without known coronary artery disease. Am J Cardiol. 2015 Jun 1;115(11):1518-22. doi: 10.1016/j.amjcard.2015.02.054. Epub 2015 Mar 14.
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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, Prof. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the HeartTrends device for the detection of myocardial ischemia (time frame: 6 month). 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 NCT01657006, which also lists 2 linked publications.
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 19 Mar 2015.