Angina PectorisNCT02530021
Heart Rate Variability (HRV) Testing Compared With Exercise Stress Test in Hospitalized Patients With Chest Pain
An observational study of Angina Pectoris and Ischemic Heart Disease, run by Meir Medical Center at 1 site in Israel.
Trial summary
There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Ischemic Heart Disease
- What is being tested?
- Heart rate monitor
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with suspected ischemic heart disease requiring further evaluation.
Who may be able to join
- Adult patients
- Hospitalized for Chest pain
- Intermediate probability for ischemic heart disease
- Selected management strategy is non invasive cardiac stress testing
Who cannot join
- Active Ischemic symptoms
- ECG changes suggestive of myocardial ischemia
- Troponin elevation on blood tests
- Atrial flutter
- Multiple APB's or VPB's on resting ECG
Trial locations and contacts
1 site in 1 country.
Olga Zyabkin, MD contact
About this study
Official title: Sixty Minutes Heart Rate Variability Testing Compared With Non-invasive Exercise Stress Test in Hospitalized Patients With Suspected Angina Pectoris
There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded.
The current management for these patients is to perform a non invasive test in order to classify their risk.
Read more
Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. The test is limited for many patients, because of un-ability to exercise, or because of non-interpetable Electro Cardio-Graphy (ECG).
Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate variability testing is a non-invasive ECG monitoring technique.
The study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.
Read the detailed description
Ischemic heart disease is among the leading causes of death and disability in the modern world. Effective treatment for cardiac ischemia is based on identification of the proper patients and assigning prompt treatment to those patients.
It is not simple identifying the proper patients. There are many patients complaining of typical anginal chest pain without coronary heart disease, and there are many patients with active angina who complain of non-typical symptoms or who don't feel any symptoms.
Management of hospitalized patients with suspected angina pectoris is based on their complaints, their risk factors and laboratory results (ECG, troponin). They are classified into low-risk, high risk and intermediate.
Intermediate risk patients usually require additional testing in the hospital in order to re-classify them into high or low risk.
Heart rate variability is a well-known marker of active cardiac ischemia. The investigators plan to perform a 60 minute heart rate variability monitoring.
- Conditions
- Angina Pectoris, Ischemic Heart Disease
- Being tested
- Heart rate monitor
- Keywords
- Ischemic heart disease, Heart rate variability, Exercise Strss Test
- Medical subject headings
- Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate monitorOther
One hour non-invasive ECG heart rate variability monitoring. The results will be blinded and interpreted independantly. Study results will not effect patient management.
| Study group | Role | What they receive |
|---|---|---|
| Heart rate monitor | Hospitalized patients with chest pain and suspected ischemic heart disease who are candidates for non invasive exercise stress test by their treating physician.
The patients will perform a one hour heart rate variability monitoring prior to the stress test. Receives: Other: Heart rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation betwen Heart rate variability test and non-onvasive testing
Heart rate variability results will be compared to non-invasive test results ordered as routine care by treating physician.
Measured: The time from non-invasive testing to hospital discharg. Estimated up to 5 Days
Secondary outcomes (1)
Correlation between Heart rate variability and invasive angiography
Patients which will undergo invasive angiography as part of selected management strategy will be compared with Heart rate variability test results.
Measured: Time from non-invasive testing to coronary angiography. Estimated up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionNov 2016 (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 Angina PectorisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnson Yoav, Meir Medical Center
- Investigators
- Yoav Arnson, MD, Principal investigator, Mei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530021
- Sponsor's protocol ID
- 0036-15
- Status last verified
- Mar 2016
- First submitted
- 19 Aug 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris PR, Stein PK, Fung GL, Drew BJ. Heart rate variability measured early in patients with evolving acute coronary syndrome and 1-year outcomes of rehospitalization and mortality. Vasc Health Risk Manag. 2014 Aug 5;10:451-64. doi: 10.2147/VHRM.S57524. eCollection 2014.
PubMed 25143740
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sixty Minutes Heart Rate Variability Testing Compared With Non-invasive Exercise Stress Test in Hospitalized Patients With Suspected Angina Pectoris
- ClinicalTrials.gov ID
- NCT02530021
- Acronym / sponsor ID
- 0036-15
- Conditions
- Angina Pectoris, Ischemic Heart Disease
- Keywords
- Ischemic heart disease, Heart rate variability, Exercise Strss Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 20 Aug 2015 (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.
There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded.
The current management for these patients is to perform a non invasive test in order to classify their risk.
Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. The test is limited for many patients, because of un-ability to exercise, or because of non-interpetable Electro Cardio-Graphy (ECG).
Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate variability testing is a non-invasive ECG monitoring technique.
The study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.
Detailed description
Ischemic heart disease is among the leading causes of death and disability in the modern world. Effective treatment for cardiac ischemia is based on identification of the proper patients and assigning prompt treatment to those patients.
It is not simple identifying the proper patients. There are many patients complaining of typical anginal chest pain without coronary heart disease, and there are many patients with active angina who complain of non-typical symptoms or who don't feel any symptoms.
Management of hospitalized patients with suspected angina pectoris is based on their complaints, their risk factors and laboratory results (ECG, troponin). They are classified into low-risk, high risk and intermediate.
Intermediate risk patients usually require additional testing in the hospital in order to re-classify them into high or low risk.
Heart rate variability is a well-known marker of active cardiac ischemia. The investigators plan to perform a 60 minute heart rate variability monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart rate monitor | – | Other: Heart rate monitorHospitalized patients with chest pain and suspected ischemic heart disease who are candidates for non invasive exercise stress test by their treating physician. The patients will perform a one hour heart rate variability monitoring prior to the stress test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with suspected ischemic heart disease requiring further evaluation.
Key inclusion criteria (4 listed)
- Adult patients
- Hospitalized for Chest pain
- Intermediate probability for ischemic heart disease
- Selected management strategy is non invasive cardiac stress testing
Key exclusion criteria (5 listed)
- Active Ischemic symptoms
- ECG changes suggestive of myocardial ischemia
- Troponin elevation on blood tests
- Atrial flutter
- Multiple APB's or VPB's on resting ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate monitorOne hour non-invasive ECG heart rate variability monitoring. The results will be blinded and interpreted independantly. Study results will not effect patient management. | Other | Heart rate monitor |
Primary outcome
Correlation betwen Heart rate variability test and non-onvasive testing
Time frame: The time from non-invasive testing to hospital discharg. Estimated up to 5 Days
Heart rate variability results will be compared to non-invasive test results ordered as routine care by treating physician.
1 secondary outcome
Correlation between Heart rate variability and invasive angiography
Time frame: Time from non-invasive testing to coronary angiography. Estimated up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 25143740Harris PR, Stein PK, Fung GL, Drew BJ. Heart rate variability measured early in patients with evolving acute coronary syndrome and 1-year outcomes of rehospitalization and mortality. Vasc Health Risk Manag. 2014 Aug 5;10:451-64. doi: 10.2147/VHRM.S57524. eCollection 2014.
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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.
Olga Zyabkin, MD contact
Yoav Arnson, MD principal investigator
Mei 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 Angina Pectoris and Ischemic Heart Disease, run by Meir 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 4 inclusion and 5 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 16 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoav Arnson, MD (97297472120, yoav.arnson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation betwen Heart rate variability test and non-onvasive testing (time frame: The time from non-invasive testing to hospital discharg. Estimated up to 5 Days). 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 NCT02530021, 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 16 Mar 2016.