Acute Coronary SyndromeNCT00339105
The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain
An observational study of Acute Coronary Syndrome, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Jan 2007
- 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
Who may be able to join
- Age ≥18 years
- Patients with chest pain, with possible ACS.
- Patients admitted to the 'chest pain unit'
- Chest pain appeared within 24 hours prior to admission to the 'chest pain unit'
- No history of trauma or any other evident medical cause of chest pain
- Signed an Informed Consent
Who cannot join
- Implanted pacemaker or defibrillator
- History of trauma or other evident medical cause of chest pain
- Patients admitted to Intensive Cardiac Care Unit or intermediate Cardiac Care Unit
- Patients discharged from the ER
- Patients with Bundle-Branch-Block or other intra-ventricular delay of more than 120 mSec
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Chest Pain Unit, ER, Sheba Medical Center, Tel-Hashomer
Ramat Gan
Shlomi Matetzky, MD
About this study
The purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest pain.
Read the detailed description
Introduction:
Chest pain is the leading cause of urgent admission to the Emergency Department (ED) in western countries.Acute Coronary Syndrome(ACS) 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.
Objectives:
To evaluate the usefulness of High Frequency mid-QRS analysis in identifying the ischemic patients out of all patients presenting to the Emergency Room (ER) with chest pain.
Comparisons:
A continuous High Frequency Mid-QRS recording will be performed using the HyperQ System (BSP Ltd.) and compared to clinical, electrophysiologic and laboratory results. The golden standards used to compare the methods will be either CT-Angio, Echocardiography or Cardiac SPECT. A follow-up inquiry will be performed after 3 months and Coronary Angiography results will be sought and compared as well.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute, Coronary, Syndrome, HyperQ, High, Frequency, ECG, chest, pain
- Medical subject headings
- Acute Coronary Syndrome, Syndrome, Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJan 2007
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.
- More trials run by Sheba Medical CenterThe 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
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Shlomi Matetzky, MD, Principal investigator, Head of Chest Pain Unit, ER, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339105
- Sponsor's protocol ID
- SHEBA-06-4114-SM-CTIL
- Status last verified
- Jan 2007
- First submitted
- 19 Jun 2006
- Last updated
- 17 Jan 2007
- Results posted
- No
Publications
Abboud S, Zlochiver S. High-frequency QRS electrocardiogram for diagnosing and monitoring ischemic heart disease. J Electrocardiol. 2006 Jan;39(1):82-6. doi: 10.1016/j.jelectrocard.2005.09.007. No abstract available.
PubMed 16387057
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain
- ClinicalTrials.gov ID
- NCT00339105
- Acronym / sponsor ID
- SHEBA-06-4114-SM-CTIL
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute, Coronary, Syndrome, HyperQ, High, Frequency, ECG, chest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2006
- Study completion
- Jan 2007
- First posted
- 20 Jun 2006 (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 purpose of the study is to assess the usefulness of high Frequency mid-QRS analysis in identifying the ischemic origin of patients presenting to the Emergency Room (ER)with Chest pain.
Detailed description
Introduction:
Chest pain is the leading cause of urgent admission to the Emergency Department (ED) in western countries.Acute Coronary Syndrome(ACS) 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.
Objectives:
To evaluate the usefulness of High Frequency mid-QRS analysis in identifying the ischemic patients out of all patients presenting to the Emergency Room (ER) with chest pain.
Comparisons:
A continuous High Frequency Mid-QRS recording will be performed using the HyperQ System (BSP Ltd.) and compared to clinical, electrophysiologic and laboratory results. The golden standards used to compare the methods will be either CT-Angio, Echocardiography or Cardiac SPECT. A follow-up inquiry will be performed after 3 months and Coronary Angiography results will be sought and compared as well.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Patients with chest pain, with possible ACS.
- Patients admitted to the 'chest pain unit'
- Chest pain appeared within 24 hours prior to admission to the 'chest pain unit'
- No history of trauma or any other evident medical cause of chest pain
Key exclusion criteria (5 listed)
- Implanted pacemaker or defibrillator
- History of trauma or other evident medical cause of chest pain
- Patients admitted to Intensive Cardiac Care Unit or intermediate Cardiac Care Unit
- Patients discharged from the ER
- Patients with Bundle-Branch-Block or other intra-ventricular delay of more than 120 mSec
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2007.
- Background: PubMed 16387057Abboud S, Zlochiver S. High-frequency QRS electrocardiogram for diagnosing and monitoring ischemic heart disease. J Electrocardiol. 2006 Jan;39(1):82-6. doi: 10.1016/j.jelectrocard.2005.09.007. No abstract available.
- BSP Ltd. is the company that developed the HyperQ systemLink provided by the sponsor.
Related trials for Acute Coronary Syndrome
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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AI-Assisted Interpretation of Cardiac CT in the Emergency Department
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Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Shlomi Matetzky, MD principal investigator
Head of Chest Pain Unit, ER, Sheba 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, run by Sheba 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 6 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 17 Jan 2007. 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 Shlomi Matetzky, MD (+972-52-6667122, shlomi.matetzky@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339105, 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 17 Jan 2007.