Acute Coronary SyndromeNCT01185899
Usefulness of High-frequency QRS Analysis in the Evaluation of Patients With Chest Pain
An observational study of Acute Coronary Syndrome and STEMI, run by Ori Galante at 1 site in Israel.
Trial summary
Accurate detection of a heart attack (an acute myocardial infarction) is one of the most pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not very accurate, especially at the beginning of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, STEMI, NSTEMI
- How many people
- 324 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Aug 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 arriving to the emergency department of Soroka University Medical Center with chest pain that is suspected of being due to acute coronary syndrome
Who may be able to join
- Patients with chest pain, suspected to have ACS
- Duration of chest pain greater than 20 minutes
- Time from onset of chest pain less than 12h
- Signed an informed consent
Who cannot join
- History of trauma or any other evident medical cause of chest pain
- Prior coronary artery bypass graft
- Pre-excitation syndrome (example WPW)
- Atrial Fibrillation or significant ventricular arrhythmia
- Bundle branch block, intraventricular conduction delay or
- QRS duration greater than 120 ms
- Implanted pacemaker or defibrillator
- Patients who received fibrinolytic therapy, glycoprotein IIb or IIIa inhibitors before the initial ECG recording
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Usefulness of High-frequency QRS Analysis in the Evaluation of Patients Presenting to the Emergency Department With Chest Pain
Accurate detection of a heart attack (an acute myocardial infarction) is one of the most pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not very accurate, especially at the beginning of a heart attack. A new technique for analysing a special part of the ECG may provide more accurate detection of a heart attack. The study hypothesis is that this new technique, the HFQRS analysis, will provide important additional information to that available from the regular ECG.
Read the detailed description
Chest pain is one of the leading reasons for hospital emergency department (ED) visits worldwide. In the United States (US), over 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. Nearly half of patients hospitalized for unstable angina eventually receive a non-cardiac-related diagnosis. Nonetheless, 2-8% of patients with myocardial infarction (MI) are inappropriately discharged from the ED and mortality rates among patients with an MI who were mistakenly sent home are disproportionately higher (25-33%) than those among patients who were admitted.
Although the ECG is a mainstay in the management of suspected ACS, it has major limitations in both sensitivity and specificity for diagnosis of ACS. The initial 12-lead ECG in the ED is often non-diagnostic in ACS patients, especially in non-ST elevation MI (NSTEMI) and unstable angina (UA), and therefore cannot rule-out ischemia or infarction. Elevation in serum biomarkers is usually not detectable for 4-6 hours after an MI, and some patients do not show a biomarker elevation for as long as 12 hours. Consequently, new clinical tools for early risk stratification of patients with acute chest pain are being sought.
Conventional analysis of ST segment deviations aims to detect repolarization abnormalities. However, ischemia may also bring about changes in the depolarization phase of the electrical cardiac cycle. These depolarization changes can be detected and quantified using analysis of the high-frequency components of the QRS complex (HFQRS). HFQRS analysis has been previously reported to be a sensitive method for detection of demand ischemia during exercise testing. 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
- Acute Coronary Syndrome, STEMI, NSTEMI, Unstable Angina, Chest Pain
- Keywords
- heart attack, acute myocardial infarction, STEMI, NSTEMI, Unstable Angina, suspected acute coronary syndrome, Non-ischemic chest pain
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Chest Pain, 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 |
|---|---|---|
| Suspected ACS patients | Patients presenting with chest pain to the Emergency Department, who are suspected of having ACS, will be asked to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis or rule-out of acute coronary syndrome
The primary end-point of the study is definite discharge diagnosis or rule-out of acute coronary syndrome, based on cardiac biomarkers, ECG changes, clinical symptoms and cardiac imaging tests.
Measured: diagnosis or rule-out of ACS will be determined at two time points: 1) upon diacharge when discharge diagnosis is determined. Follow up information will be obtained one month post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionAug 2013
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 Coronary SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ori Galante
- Sponsor type
- University, hospital or other
- Collaborators
- BSP Biological Signal Processing Ltd.
- Responsible party
- Sponsor-investigator, Ori Galante, Soroka University Medical Center
- Investigators
- Doron Zahger, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185899
- Sponsor's protocol ID
- sor505310ctil
- Status last verified
- Nov 2015
- First submitted
- 18 Aug 2010
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Galante O, Amit G, Granot Y, Davrath LR, Abboud S, Zahger D. High-frequency QRS analysis in the evaluation of chest pain in the emergency department. J Electrocardiol. 2017 Jul-Aug;50(4):457-465. doi: 10.1016/j.jelectrocard.2017.02.009. Epub 2017 Feb 20.
PubMed 28341306
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of High-frequency QRS Analysis in the Evaluation of Patients Presenting to the Emergency Department With Chest Pain
- ClinicalTrials.gov ID
- NCT01185899
- Acronym / sponsor ID
- sor505310ctil
- Conditions
- Acute Coronary Syndrome, STEMI, NSTEMI, Unstable Angina, Chest Pain
- Keywords
- heart attack, acute myocardial infarction, STEMI, NSTEMI, Unstable Angina, suspected acute coronary syndrome, Non-ischemic chest pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Ori GalanteUniversity, hospital or other
- Collaborators
- BSP Biological Signal Processing Ltd.
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Aug 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.
Accurate detection of a heart attack (an acute myocardial infarction) is one of the most pressing needs in medicine. Recordings of the electrocardiogram (ECG) (electrical activity of the heart) are one of the first tools used to diagnose a heart attack, but the ECG is not very accurate, especially at the beginning of a heart attack. A new technique for analysing a special part of the ECG may provide more accurate detection of a heart attack. The study hypothesis is that this new technique, the HFQRS analysis, will provide important additional information to that available from the regular ECG.
Detailed description
Chest pain is one of the leading reasons for hospital emergency department (ED) visits worldwide. In the United States (US), over 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. Nearly half of patients hospitalized for unstable angina eventually receive a non-cardiac-related diagnosis. Nonetheless, 2-8% of patients with myocardial infarction (MI) are inappropriately discharged from the ED and mortality rates among patients with an MI who were mistakenly sent home are disproportionately higher (25-33%) than those among patients who were admitted.
Although the ECG is a mainstay in the management of suspected ACS, it has major limitations in both sensitivity and specificity for diagnosis of ACS. The initial 12-lead ECG in the ED is often non-diagnostic in ACS patients, especially in non-ST elevation MI (NSTEMI) and unstable angina (UA), and therefore cannot rule-out ischemia or infarction. Elevation in serum biomarkers is usually not detectable for 4-6 hours after an MI, and some patients do not show a biomarker elevation for as long as 12 hours. Consequently, new clinical tools for early risk stratification of patients with acute chest pain are being sought.
Conventional analysis of ST segment deviations aims to detect repolarization abnormalities. However, ischemia may also bring about changes in the depolarization phase of the electrical cardiac cycle. These depolarization changes can be detected and quantified using analysis of the high-frequency components of the QRS complex (HFQRS). HFQRS analysis has been previously reported to be a sensitive method for detection of demand ischemia during exercise testing. 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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected ACS patients | – | –Patients presenting with chest pain to the Emergency Department, who are suspected of having ACS, will be asked to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients arriving to the emergency department of Soroka University Medical Center with chest pain that is suspected of being due to acute coronary syndrome
Key inclusion criteria (4 listed)
- Patients with chest pain, suspected to have ACS
- Duration of chest pain greater than 20 minutes
- Time from onset of chest pain less than 12h
- Signed an informed consent
Key exclusion criteria (8 listed)
- History of trauma or any other evident medical cause of chest pain
- Prior coronary artery bypass graft
- Pre-excitation syndrome (example WPW)
- Atrial Fibrillation or significant ventricular arrhythmia
- Bundle branch block, intraventricular conduction delay or
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 or rule-out of acute coronary syndrome
Time frame: diagnosis or rule-out of ACS will be determined at two time points: 1) upon diacharge when discharge diagnosis is determined. Follow up information will be obtained one month post discharge
The primary end-point of the study is definite discharge diagnosis or rule-out of acute coronary syndrome, based on cardiac biomarkers, ECG changes, clinical symptoms and cardiac imaging tests.
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 20 Nov 2015.
- Derived from this study: PubMed 28341306Galante O, Amit G, Granot Y, Davrath LR, Abboud S, Zahger D. High-frequency QRS analysis in the evaluation of chest pain in the emergency department. J Electrocardiol. 2017 Jul-Aug;50(4):457-465. doi: 10.1016/j.jelectrocard.2017.02.009. Epub 2017 Feb 20.
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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 Acute Coronary Syndrome and STEMI, run by Ori Galante 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 8 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 20 Nov 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?
diagnosis or rule-out of acute coronary syndrome (time frame: diagnosis or rule-out of ACS will be determined at two time points: 1) upon diacharge when discharge diagnosis is determined. Follow up information will be obtained one month post discharge). 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 NCT01185899, 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 20 Nov 2015.