Acute Myocardial Infarction With ST Segment ElevationNehb-STEMINCT00623896
3 Nehb Precordial Leads Anterior, Dorsalis and Inferior Allow Accurate Diagnostics of Different Heart Conditions
An observational study of Acute Myocardial Infarction With ST Segment Elevation, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The method of ECG recording with the use of three bipolar leads A (anterior), D dorsalis) and J (or I - inferior) was introduced in 1938 by German electrophysiologist W. Nehb. Being positioned on the chest in the immediate proximity to the heart, and being aligned to the anatomic position of the heart, these leads are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction With ST Segment Elevation
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Aug 2008
- 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: All STEMI Patients admitted to ICCU during the study period with ST elevations presenting on first 12 lead ECG performed on admition.
Who may be able to join
- Age ≥ 18 years
- ST elevation in more than 2 contiguous leads (> 1 mV in limb leads \& V5-V6; more than 2 mm in V1-V4)
- Complains of chest, neck, jaw, arm, epigastric or back pain or dyspnea
- Patients directly transferred to the coronary care unit.
Who cannot join
- Unconscious patients
- Unwillingness to participate in the study
- Presence of LBBB
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center Intensive Coronary Care Unit
Tsrifin, 73000
Ilya Litovchik, MD, +972577345900, ilitovchik@gmail.com
Ilya Litovchik, MD
About this study
Official title: Nehb 3-Lead Bipolar Leads for Rapid Diagnosis & Treatment of STEMI
The method of ECG recording with the use of three bipolar leads A (anterior), D dorsalis) and J (or I - inferior) was introduced in 1938 by German electrophysiologist W. Nehb. Being positioned on the chest in the immediate proximity to the heart, and being aligned to the anatomic position of the heart, these leads are very sensitive and allow accurate diagnostics of different heart conditions. All the active leads are placed on anterolateral plane of the chest wall requiring little anatomical window making this technique convenient for express diagnostics using compact electrocardiographic devices without any loss of valuable information.
Active electrodes are located on the chest in the following order: 1st- red standard electrode placed in the second intercostal space to the right from sternum corresponding to V1 for standard 12-lead ECG recording, 2nd- green standard lead placed in the position corresponding to V4; 3rd- yellow in the position V7. Then ECG recorded as if in the I standard lead would be defined as Nehb's D, which records the potential on the posterior left ventricle wall; II standard lead would produce Nehb's A which corresponds to the potential on the anterior wall of the left ventricle, and III standard lead would record Nehb's J, which reflects the potential on the diaphragmatic surface of heart.
Read more
Been simple and informative, this ECG recording modality may be applicable for usage with compact portable cardiographer devices for express diagnosis in different situations and may allow faster and more adequate outpatient response in the case of emergencies.
Nehb 3 leads ECG can provide the clinician with portable, reliable, comprehensive and constant ECG monitoring and by this facilitate rapid diagnosis and treatment of STEMI.
Read the detailed description
General Objective: to compare the diagnostic ability of Nehb 3 lead ECG and standard 12 lead ECG in patients presenting to EMS with STEMI.
Inclusion criteria:
Age ≥ 18 years ST elevation in more than 2 contiguous leads (> 1 mV in limb leads \& V5-V6; more than 2 mm in V1-V4) Complains of chest, neck, jaw, arm, epigastric or back pain or dyspnea Patients directly transferred to the coronary care unit.
Exclusion criteria:
Unconscious patients Unwillingness to participate in the study Presence of LBBB
Protocol:
100 patients with STEMI will be included. After initial 12 leads ECG made by EMS personnel will show changes consistent with STEMI, a portable Nehb 3 leads (ECG MiniMonitor CG 5000 N) recorder will be connected to the patient. 12 leads ECG recording will be performed according to the EMS and the CCU practices, i.e: before transport, on admission, before and after reperfusion therapy (thrombolysis or PCI), during angina episodes, and every 24 hours since admission. Nehb tracing will be recorded in parallel with standard 12 leads ECG.
ECG findings of standard 12 leads ECG and Nehb 3 leads ECG will be compared for:
Presence of ST elevation (defined as presence of ST segment elevation in 2 or more contiguous leads in 12 leads ECG versus presence of ST segment elevation or depression in 1 or more leads in Nehb ECG).
Area at risk [8] (defined as sum of amplitudes of ST segment elevations of all leads that demonstrate this in 12 leads ECG versus sum of amplitudes of ST segment elevations of all leads in Nehb ECG)
Severity of ischemia [8] (defined as disappearance of S waves in leads with normally negative QRS or J point elevation over more than 50% of R wave height in leads with normally positive QRS in 12 leads versus Nehb ECG)
Time discrimination (defined as presence of ST segment elevation at any time of recording and total amount of such events by 12 leads ECG versus Nehb ECG).
- Keywords
- Nehb, ST Elevation Myocardial Infarcton, STEMI, ECG
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of ST Elevations in Nehb Tracing in all patients with determined STEMI in Standard 12-leads ECG.
Measured: On patients' admition to EMS/ICCU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2008 (estimated)
- Study completionAug 2008 (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 Acute Myocardial Infarction With ST Segment ElevationStudies 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
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Ilya Litovchik, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623896
- Sponsor's protocol ID
- 174/07
- Acronym
- Nehb-STEMI
- Status last verified
- Jun 2007
- First submitted
- 17 Feb 2008
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Nehb W. Zur Standardisierung der Brustwandableitungen des Elektrokardiogrammen. Kin. Wochenschz. 17 (1938):1807-1811.// Pollock, P. A comparison of Nehb's bipolar chest leads and the standard 12-lead electrocardiogram in cases of myocardial infarction. American Heart Journal, Research Assistant in Medicine. (1955) 68-71.// De Luca et al: Time Delay to Treatment and Mortality in Primary Angioplasty for Acute Myocardial Infarction: Every Minute of Delay Counts. Circulation 109 (2004): 1224// Atar et al: Electrocardiographic Diagnosis of ST-elevation Myocardial Infarction. Cardiol Clin 24 (2006) 343-365// V. N. Dhruva et al: ST-Segment Analysis Using Wireless Technology in Acute Myocardial Infarction (STAT-MI) Trial J. Am. Coll. Cardiol. 2007;50;509-513//
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nehb 3-Lead Bipolar Leads for Rapid Diagnosis & Treatment of STEMI
- ClinicalTrials.gov ID
- NCT00623896
- Acronym / sponsor ID
- Nehb-STEMI / 174/07
- Keywords
- Nehb, ST Elevation Myocardial Infarcton, STEMI, ECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 26 Feb 2008 (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 method of ECG recording with the use of three bipolar leads A (anterior), D dorsalis) and J (or I - inferior) was introduced in 1938 by German electrophysiologist W. Nehb. Being positioned on the chest in the immediate proximity to the heart, and being aligned to the anatomic position of the heart, these leads are very sensitive and allow accurate diagnostics of different heart conditions. All the active leads are placed on anterolateral plane of the chest wall requiring little anatomical window making this technique convenient for express diagnostics using compact electrocardiographic devices without any loss of valuable information.
Active electrodes are located on the chest in the following order: 1st- red standard electrode placed in the second intercostal space to the right from sternum corresponding to V1 for standard 12-lead ECG recording, 2nd- green standard lead placed in the position corresponding to V4; 3rd- yellow in the position V7. Then ECG recorded as if in the I standard lead would be defined as Nehb's D, which records the potential on the posterior left ventricle wall; II standard lead would produce Nehb's A which corresponds to the potential on the anterior wall of the left ventricle, and III standard lead would record Nehb's J, which reflects the potential on the diaphragmatic surface of heart.
Been simple and informative, this ECG recording modality may be applicable for usage with compact portable cardiographer devices for express diagnosis in different situations and may allow faster and more adequate outpatient response in the case of emergencies.
Nehb 3 leads ECG can provide the clinician with portable, reliable, comprehensive and constant ECG monitoring and by this facilitate rapid diagnosis and treatment of STEMI.
Detailed description
General Objective: to compare the diagnostic ability of Nehb 3 lead ECG and standard 12 lead ECG in patients presenting to EMS with STEMI.
Inclusion criteria:
Age ≥ 18 years ST elevation in more than 2 contiguous leads (> 1 mV in limb leads \& V5-V6; more than 2 mm in V1-V4) Complains of chest, neck, jaw, arm, epigastric or back pain or dyspnea Patients directly transferred to the coronary care unit.
Exclusion criteria:
Unconscious patients Unwillingness to participate in the study Presence of LBBB
Protocol:
100 patients with STEMI will be included. After initial 12 leads ECG made by EMS personnel will show changes consistent with STEMI, a portable Nehb 3 leads (ECG MiniMonitor CG 5000 N) recorder will be connected to the patient. 12 leads ECG recording will be performed according to the EMS and the CCU practices, i.e: before transport, on admission, before and after reperfusion therapy (thrombolysis or PCI), during angina episodes, and every 24 hours since admission. Nehb tracing will be recorded in parallel with standard 12 leads ECG.
ECG findings of standard 12 leads ECG and Nehb 3 leads ECG will be compared for:
Presence of ST elevation (defined as presence of ST segment elevation in 2 or more contiguous leads in 12 leads ECG versus presence of ST segment elevation or depression in 1 or more leads in Nehb ECG).
Area at risk [8] (defined as sum of amplitudes of ST segment elevations of all leads that demonstrate this in 12 leads ECG versus sum of amplitudes of ST segment elevations of all leads in Nehb ECG)
Severity of ischemia [8] (defined as disappearance of S waves in leads with normally negative QRS or J point elevation over more than 50% of R wave height in leads with normally positive QRS in 12 leads versus Nehb ECG)
Time discrimination (defined as presence of ST segment elevation at any time of recording and total amount of such events by 12 leads ECG versus Nehb ECG).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All STEMI Patients admitted to ICCU during the study period with ST elevations presenting on first 12 lead ECG performed on admition.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- ST elevation in more than 2 contiguous leads (> 1 mV in limb leads \& V5-V6; more than 2 mm in V1-V4)
- Complains of chest, neck, jaw, arm, epigastric or back pain or dyspnea
- Patients directly transferred to the coronary care unit.
Key exclusion criteria (3 listed)
- Unconscious patients
- Unwillingness to participate in the study
- Presence of LBBB
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
Evidence of ST Elevations in Nehb Tracing in all patients with determined STEMI in Standard 12-leads ECG.
Time frame: On patients' admition to EMS/ICCU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2008.
- BackgroundNehb W. Zur Standardisierung der Brustwandableitungen des Elektrokardiogrammen. Kin. Wochenschz. 17 (1938):1807-1811.// Pollock, P. A comparison of Nehb's bipolar chest leads and the standard 12-lead electrocardiogram in cases of myocardial infarction. American Heart Journal, Research Assistant in Medicine. (1955) 68-71.// De Luca et al: Time Delay to Treatment and Mortality in Primary Angioplasty for Acute Myocardial Infarction: Every Minute of Delay Counts. Circulation 109 (2004): 1224// Atar et al: Electrocardiographic Diagnosis of ST-elevation Myocardial Infarction. Cardiol Clin 24 (2006) 343-365// V. N. Dhruva et al: ST-Segment Analysis Using Wireless Technology in Acute Myocardial Infarction (STAT-MI) Trial J. Am. Coll. Cardiol. 2007;50;509-513//
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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.
Ilya Litovchik, MD principal investigator
Assaf-Harofeh 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 Acute Myocardial Infarction With ST Segment Elevation, run by Assaf-Harofeh 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 3 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 26 Feb 2008. 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 Ilya Litovchik, MD (+972577345900, ilitovchik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of ST Elevations in Nehb Tracing in all patients with determined STEMI in Standard 12-leads ECG. (time frame: On patients' admition to EMS/ICCU). 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 NCT00623896, 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 26 Feb 2008.