Myocardial InfarctionNCT01150825
Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction
An observational study of Myocardial Infarction, run by BSP Biological Signal Processing Ltd. at 1 site in Israel.
Trial summary
The primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jun 2011
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with confirmed AMI in the intensive cardiac care unit (ICCU) of Soroka Medical Center (Beer Sheva, Israel), who are expected to undergo percutaneous coronary intervention (PCI) will be asked to participate in the study. These include both ST-elevation MI (STEMI) and non ST-elevation MI (NSTEMI) patients, with positive biomarkers and clear ongoing electrocardiographic or clinical evidence of ischemia.
Who may be able to join
- Age > 40 years (men and women)
- Time from onset of chest pain ≤ 12h
- AMI confirmed by biomarkers
- Clinical or electrocardiographic evidence of ischemia during recording
- Signed an informed consent
Who cannot join
- Prior MI
- Prior CABG
- pre-excitation syndrome (e.g. WP)
- Atrial Fibrillation or significant ventricular arrhythmia
- BBB, intraventricular conduction delay or QRS duration > 120 ms
- Implanted pacemaker or defibrillator
- Left-ventricular hypertrophy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 84101
About this study
The primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI.
Read the detailed description
Chest pain is one of the leading reasons of hospital emergency department (ED) visits worldwide. In the US, approximately 6 million people annually undergo evaluation in the ED for acute chest pain. Despite the wealth of knowledge available about acute coronary syndrome (ACS), this condition continues to be among the most difficult to predict or diagnose. Misdiagnoses may lead to discharge of patients with ACS, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have ACS.
More than 2/3 of the patients with ACS have unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Conventional ECG has low sensitivity of less than 50% in diagnosing these conditions. As the initial ECG in the ED is often non-diagnostic in ACS patients, the diagnosis of ST-elevation myocardial infarction (STEMI) during its early stages may also be difficult.
Analysis of high-frequency QRS components (HFQRS), which quantifies changes in the depolarization phase of the cardiac cycle, has been previously reported to be a sensitive method for detection of demand ischemia. Preliminary studies have shown that HFQRS-derived indices can also identify supply ischemia caused by prolonged balloon occlusion, and transient ischemic episodes in patients with chest pain.
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, NSTEMI, acute ischemia, non-invasive diagnosis, elevated troponin
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels | |
| NSTEMI | Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Acute Myocardial Infarction
The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.
Measured: Prior to hospitalization release
Secondary outcomes (1)
HFQRS analysis for detecting NSTEMI
To evaluate the usefulness of HFQRS analysis in early detection of non-ST segment elevation myocardial infarction (NSTEMI).
Measured: Post data processing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (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 Myocardial InfarctionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BSP Biological Signal Processing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Doron Zahger, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150825
- Sponsor's protocol ID
- ER_02_5023
- Status last verified
- Feb 2011
- First submitted
- 10 Jun 2010
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Amit G, Galante O, Davrath LR, Luria O, Abboud S, Zahger D. High-frequency QRS analysis in patients with acute myocardial infarction: a preliminary study. Ann Noninvasive Electrocardiol. 2013 Mar;18(2):149-56. doi: 10.1111/anec.12023. Epub 2012 Nov 22.
PubMed 23530485
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01150825
- Acronym / sponsor ID
- ER_02_5023
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, NSTEMI, acute ischemia, non-invasive diagnosis, elevated troponin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BSP Biological Signal Processing Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Jun 2010 (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 primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI.
Detailed description
Chest pain is one of the leading reasons of hospital emergency department (ED) visits worldwide. In the US, approximately 6 million people annually undergo evaluation in the ED for acute chest pain. Despite the wealth of knowledge available about acute coronary syndrome (ACS), this condition continues to be among the most difficult to predict or diagnose. Misdiagnoses may lead to discharge of patients with ACS, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have ACS.
More than 2/3 of the patients with ACS have unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Conventional ECG has low sensitivity of less than 50% in diagnosing these conditions. As the initial ECG in the ED is often non-diagnostic in ACS patients, the diagnosis of ST-elevation myocardial infarction (STEMI) during its early stages may also be difficult.
Analysis of high-frequency QRS components (HFQRS), which quantifies changes in the depolarization phase of the cardiac cycle, has been previously reported to be a sensitive method for detection of demand ischemia. Preliminary studies have shown that HFQRS-derived indices can also identify supply ischemia caused by prolonged balloon occlusion, and transient ischemic episodes in patients with chest pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | –Patients with ST segment elevation myocardial infarction, verified by elevated troponin levels |
| NSTEMI | – | –Patients with non-ST segment elevation myocardial infarction, verified by elevated levels of troponin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with confirmed AMI in the intensive cardiac care unit (ICCU) of Soroka Medical Center (Beer Sheva, Israel), who are expected to undergo percutaneous coronary intervention (PCI) will be asked to participate in the study. These include both ST-elevation MI (STEMI) and non ST-elevation MI (NSTEMI) patients, with positive biomarkers and clear ongoing electrocardiographic or clinical evidence of ischemia.
Key inclusion criteria (5 listed)
- Age > 40 years (men and women)
- Time from onset of chest pain ≤ 12h
- AMI confirmed by biomarkers
- Clinical or electrocardiographic evidence of ischemia during recording
- Signed an informed consent
Key exclusion criteria (7 listed)
- Prior MI
- Prior CABG
- pre-excitation syndrome (e.g. WP)
- Atrial Fibrillation or significant ventricular arrhythmia
- BBB, intraventricular conduction delay or QRS duration > 120 ms
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
Diagnosis of Acute Myocardial Infarction
Time frame: Prior to hospitalization release
The primary end-point of the study is diagnosis of acute myocardial infarction, based on cardiac biomarkers, ECG changes clinical symptoms and coronary angiography.
1 secondary outcome
HFQRS analysis for detecting NSTEMI
Time frame: Post data processing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
- Derived from this study: PubMed 23530485Amit G, Galante O, Davrath LR, Luria O, Abboud S, Zahger D. High-frequency QRS analysis in patients with acute myocardial infarction: a preliminary study. Ann Noninvasive Electrocardiol. 2013 Mar;18(2):149-56. doi: 10.1111/anec.12023. Epub 2012 Nov 22.
- Sponsor WebsiteLink provided by the sponsor.
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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.
Doron Zahger, MD principal investigator
Soroka University 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 Myocardial Infarction, run by BSP Biological Signal Processing Ltd. 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 5 inclusion and 7 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 8 Feb 2011. 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 Doron Zahger, MD (+972-8-6403468, dzahger@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Acute Myocardial Infarction (time frame: Prior to hospitalization release). 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 NCT01150825, 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 8 Feb 2011.