Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT00339105
Status:
UNKNOWN
Last Update Posted:
2007-01-17
First Post:
2006-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D013577', 'term': 'Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2007-01-14', 'studyFirstSubmitDate': '2006-06-19', 'studyFirstSubmitQcDate': '2006-06-19', 'lastUpdatePostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acute', 'Coronary', 'Syndrome', 'HyperQ', 'High', 'Frequency', 'ECG', 'chest', 'pain'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '16387057', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.bsp.co.il', 'label': 'BSP Ltd. is the company that developed the HyperQ system'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Introduction:\n\nChest 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.\n\nObjectives:\n\nTo 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.\n\nComparisons:\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with chest pain, with possible ACS.\n* Patients admitted to the 'chest pain unit'\n* Chest pain appeared within 24 hours prior to admission to the 'chest pain unit'\n* No history of trauma or any other evident medical cause of chest pain\n* Signed an Informed Consent\n\nExclusion Criteria:\n\n* Implanted pacemaker or defibrillator\n* History of trauma or other evident medical cause of chest pain\n* Patients admitted to Intensive Cardiac Care Unit or intermediate Cardiac Care Unit\n* Patients discharged from the ER\n* Patients with Bundle-Branch-Block or other intra-ventricular delay of more than 120 mSec"}, 'identificationModule': {'nctId': 'NCT00339105', 'briefTitle': 'The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Usefulness of HyperQ Recordings for the Early Diagnosis of Acute Coronary Syndrome in Patients Presenting With Chest Pain', 'orgStudyIdInfo': {'id': 'SHEBA-06-4114-SM-CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shlomi Matetzky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Chest Pain Unit, ER, Sheba Medical Center, Tel-Hashomer', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Shlomi Matetzky, MD', 'role': 'CONTACT', 'email': 'shlomi.matetzky@sheba.health.gov.il', 'phone': '+972-52-6667122'}], 'overallOfficials': [{'name': 'Shlomi Matetzky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Chest Pain Unit, ER, Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}}}}