Coronary Artery DiseaseNCT01390155
Characterization of Ischemia Related Changes in Esophageal Electrocardiography
An observational study of Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Esophageal electrocardiography (eECG) has important advantages compared to standard ECG recordings. Coronary artery disease leading to myocardial ischemia is very common and has potentially severe consequences for patients. To date, the investigators don't know the influence of ischemia on the eECG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Measurement of coronary collateral flow index
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2011to May 2013
- 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: Patients referred for elective coronary angiography due to suspected or known coronary artery disease.
Who may be able to join
- Patients referred for elective coronary angiography
- Age >/= 18 years
- Written informed consent to participate to this study
Who cannot join
- Seve mitral- or aortic valve disease
- Acute coronary infarction
- Known bleeding diathesis
- Systolic blood pressure >200mmHg
- History of operations of the esophagus
- Active disease of the upper respiratory and gastroesophageal tract
Show all 10Show fewer
- Radiofrequency ablation of atrial fibrillation, less than six weeks ago
- Right and left bundle branch block
- Significant Q-waves in the surface leads as indicators for prior myocardial infarction
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Cardiology, Bern University Hospital
Bern, Canton of Bern, 3010 Bern
About this study
Esophageal electrocardiography (eECG) has important advantages compared to standard ECG recordings.
Coronary artery disease leading to myocardial ischemia is very common and has potentially severe consequences for patients. To date, the investigators don't know the influence of ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG induced by balloon occlusion of coronary arteries in patients undergoing coronary angiography.
Read the detailed description
Background
Heart rhythm disorders frequently occur in the general population and potentially have serious consequences. Atrial fibrillation, the most common atrial arrhythmia, can lead to intracardiac blood clot formation an subsequent embolisation. Esophageal electrocardiography (eECG) provides detailed information about the electrical activity of the atria. Due to the good signal quality, eECG is a promising technique for rhythm monitoring.
Patients undergoing rhythm monitoring may also show signs of other cardiac diseases, particularly coronary artery disease (CAD) due to its high prevalence. It is therefore mandatory to define the ischemic changes in the esophageal ECG.
In CAD atherosclerotic processes narrow the lumen of coronary arteries and may cause exercise-induced ischemia (stable CAD). More importantly, there is also the risk of plaque rupture and subsequent blood clot formation. This cascade can lead to total occlusion of the coronary vessel and myocardial infarction.
Coronary angiography is used to determine the severity of coronary artery stenosis. This simple approach turned out to be useful in clinical routine. However, presence or absence of coronary collaterals is one of the reasons why coronary angiography alone may fail to define the clinical relevance of CAD. Collateral vessels as natural bypasses can grow and act as "backup" blood supply of the myocardial area at risk and can therefore reduce infarct size. The coronary wedge-pressure method is recognized as the scientific and clinical gold standard. Collateralization is an important confounder which also can "mask" ischemic changes on the ECG.
The surface ECG of an important portion of patients undergoing arrhythmia screening also shows signs of myocardial ischemia due to CAD or left ventricular hypertrophy. As with the surface ECG, it is conceivable that ischemic changes occur in the eECG. The characterization of ischemia related changes in eECG is crucial in order to guarantee the proper classification of eECG events. To date, the characterization of such changes is not adequate in order to allow the reliable clinical interpretation of eECG changes.
Objective
- To characterize changes in the esophageal ECG induced by myocardial ischemia due to short-time coronary occlusion.
- To determine the influence of coronary collateral vessels on these changes.
Methods
Patients referred for elective coronary angiography will be randomized to four groups:
- Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left anterior descending (LAD) coronary artery.
- Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left circumflex artery.
- Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal right coronary artery.
- Patients undergoing temporary ischemia produced by a one-minute occlusion of the target vessel (the vessel which shows a significant stenosis and accordingly requires a therapeutical intervention).
During the occlusion, collateral flow indexes will be calculated. Simultaneously, surface ECG, esophageal ECG and intracoronary ECG will be registered.
- Conditions
- Coronary Artery Disease
- Being tested
- Measurement of coronary collateral flow index
- Keywords
- Electrocardiography, Coronary Artery Disease, Atrial Fibrillation, Heart Atria, Coronary Circulation, Ischemia
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of coronary collateral flow indexProcedure or surgery
One-minute balloon occlusion of the proximal left anterior descending coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
Measurement of coronary collateral flow indexProcedure or surgery
One-minute balloon occlusion of the proximal left circumflex artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
Measurement of coronary collateral flow indexProcedure or surgery
One-minute balloon occlusion of the proximal right coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
Measurement of coronary collateral flow indexProcedure or surgery
One-minute balloon occlusion of the target vessel (the vessel which shows a significant stenosis and accordingly requires a therapeutical intervention by balloon angioplasty and stenting) inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left anterior descending coronary artery. Receives: Procedure: Measurement of coronary collateral flow index | |
| 2 | Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left circumflex artery. Receives: Procedure: Measurement of coronary collateral flow index | |
| 3 | Patients undergoing temporary myocardial ischemia produced by a one-minute occlusion of the proximal right coronary artery. Receives: Procedure: Measurement of coronary collateral flow index | |
| 4 | Patients undergoing temporary myocardial ischemia produced by a one-minute occlusion of the target vessel. Receives: Procedure: Measurement of coronary collateral flow index |
What is being measured
The primary outcome is the main question the study is designed to answer.
ST-segment-elevation/depression in the ECG at J-point and 80ms later
Measured: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
Secondary outcomes (5)
Increase/decrease of T-wave amplitude
Measured: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
Relative ST-segment-elevation/depression
Measured: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
Sensitivity and specificity of the esophageal electrocardiogram detecting ischemic conditions (using the intracoronary ecg as gold standard)
Measured: at the end of occlusion, expected on average to be 60 seconds
New U-wave
Measured: during the whole occlusion time, expected on average to be 60 seconds
beat-to-beat alternans of the ST-segment
Measured: during the whole occlusion time, expected on average to be 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Rolf Vogel, MD, MD-PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390155
- Sponsor's protocol ID
- 058/11
- Status last verified
- May 2013
- First submitted
- 1 Jul 2011
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Ischemia Related Changes in Esophageal Electrocardiography
- ClinicalTrials.gov ID
- NCT01390155
- Acronym / sponsor ID
- 058/11
- Conditions
- Coronary Artery Disease
- Keywords
- Electrocardiography, Coronary Artery Disease, Atrial Fibrillation, Heart Atria, Coronary Circulation, Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jul 2011 (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.
Esophageal electrocardiography (eECG) has important advantages compared to standard ECG recordings.
Coronary artery disease leading to myocardial ischemia is very common and has potentially severe consequences for patients. To date, the investigators don't know the influence of ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG induced by balloon occlusion of coronary arteries in patients undergoing coronary angiography.
Detailed description
Background
Heart rhythm disorders frequently occur in the general population and potentially have serious consequences. Atrial fibrillation, the most common atrial arrhythmia, can lead to intracardiac blood clot formation an subsequent embolisation. Esophageal electrocardiography (eECG) provides detailed information about the electrical activity of the atria. Due to the good signal quality, eECG is a promising technique for rhythm monitoring.
Patients undergoing rhythm monitoring may also show signs of other cardiac diseases, particularly coronary artery disease (CAD) due to its high prevalence. It is therefore mandatory to define the ischemic changes in the esophageal ECG.
In CAD atherosclerotic processes narrow the lumen of coronary arteries and may cause exercise-induced ischemia (stable CAD). More importantly, there is also the risk of plaque rupture and subsequent blood clot formation. This cascade can lead to total occlusion of the coronary vessel and myocardial infarction.
Coronary angiography is used to determine the severity of coronary artery stenosis. This simple approach turned out to be useful in clinical routine. However, presence or absence of coronary collaterals is one of the reasons why coronary angiography alone may fail to define the clinical relevance of CAD. Collateral vessels as natural bypasses can grow and act as "backup" blood supply of the myocardial area at risk and can therefore reduce infarct size. The coronary wedge-pressure method is recognized as the scientific and clinical gold standard. Collateralization is an important confounder which also can "mask" ischemic changes on the ECG.
The surface ECG of an important portion of patients undergoing arrhythmia screening also shows signs of myocardial ischemia due to CAD or left ventricular hypertrophy. As with the surface ECG, it is conceivable that ischemic changes occur in the eECG. The characterization of ischemia related changes in eECG is crucial in order to guarantee the proper classification of eECG events. To date, the characterization of such changes is not adequate in order to allow the reliable clinical interpretation of eECG changes.
Objective
- To characterize changes in the esophageal ECG induced by myocardial ischemia due to short-time coronary occlusion.
- To determine the influence of coronary collateral vessels on these changes.
Methods
Patients referred for elective coronary angiography will be randomized to four groups:
- Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left anterior descending (LAD) coronary artery.
- Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left circumflex artery.
- Patients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal right coronary artery.
- Patients undergoing temporary ischemia produced by a one-minute occlusion of the target vessel (the vessel which shows a significant stenosis and accordingly requires a therapeutical intervention).
During the occlusion, collateral flow indexes will be calculated. Simultaneously, surface ECG, esophageal ECG and intracoronary ECG will be registered.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Measurement of coronary collateral flow indexPatients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left anterior descending coronary artery. |
| 2 | – | Procedure: Measurement of coronary collateral flow indexPatients undergoing temporary myocardial ischemia produced by a one-minute balloon occlusion of the proximal left circumflex artery. |
| 3 | – | Procedure: Measurement of coronary collateral flow indexPatients undergoing temporary myocardial ischemia produced by a one-minute occlusion of the proximal right coronary artery. |
| 4 | – | Procedure: Measurement of coronary collateral flow indexPatients undergoing temporary myocardial ischemia produced by a one-minute occlusion of the target vessel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for elective coronary angiography due to suspected or known coronary artery disease.
Key inclusion criteria (3 listed)
- Patients referred for elective coronary angiography
- Age >/= 18 years
- Written informed consent to participate to this study
Key exclusion criteria (10 listed)
- Seve mitral- or aortic valve disease
- Acute coronary infarction
- Known bleeding diathesis
- Systolic blood pressure >200mmHg
- History of operations of the esophagus
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 |
|---|---|---|
| Measurement of coronary collateral flow indexOne-minute balloon occlusion of the proximal left anterior descending coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow. | Procedure or surgery | 1 |
| Measurement of coronary collateral flow indexOne-minute balloon occlusion of the proximal left circumflex artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow. | Procedure or surgery | 2 |
| Measurement of coronary collateral flow indexOne-minute balloon occlusion of the proximal right coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow. | Procedure or surgery | 3 |
| Measurement of coronary collateral flow indexOne-minute balloon occlusion of the target vessel (the vessel which shows a significant stenosis and accordingly requires a therapeutical intervention by balloon angioplasty and stenting) inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow. | Procedure or surgery | 4 |
Primary outcome
ST-segment-elevation/depression in the ECG at J-point and 80ms later
Time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
5 secondary outcomes
Increase/decrease of T-wave amplitude
Time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
Relative ST-segment-elevation/depression
Time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
Sensitivity and specificity of the esophageal electrocardiogram detecting ischemic conditions (using the intracoronary ecg as gold standard)
Time frame: at the end of occlusion, expected on average to be 60 seconds
New U-wave
Time frame: during the whole occlusion time, expected on average to be 60 seconds
beat-to-beat alternans of the ST-segment
Time frame: during the whole occlusion time, expected on average to be 60 seconds
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 24 May 2013.
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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.
Rolf Vogel, MD, MD-PhD study director
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 Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 10 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 24 May 2013. 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 Switzerland. 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?
ST-segment-elevation/depression in the ECG at J-point and 80ms later (time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2013.