Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT01325467
Status:
UNKNOWN
Last Update Posted:
2012-03-29
First Post:
2011-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAD status', 'timeFrame': 'one month follow up', 'description': 'The main goal of this registry will be to compare sensitivity, specificity, positive and negative predictive values of the HyperQ HFQRS analysis for detecting the presence of coronary artery disease to that of standard ECG analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'high frequency QRS analysis', 'ischemia', 'exercise testing', 'diagnosis of coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This will be a registry study that will enroll patients referred for an ECG treadmill test with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information will be recorded and analyzed automatically and simultaneous with the standard ECG signals by the HyperQ System. Results of subsequent tests performed on each patient will be collected and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery disease).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients referred for an exercise ECG treadmill test with nuclear myocardial perfusion imaging (MPI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Referred for exercise MPI due to suspected coronary artery disease\n\nExclusion Criteria:\n\n* Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI)\n* Pre-excitation syndrome\n* QRS duration \\> 120 ms\n* Atrial Fibrillation or significant ventricular arrhythmia\n* Treatment with Digoxin\n* Pacemaker with 100% pacemaker dependence'}, 'identificationModule': {'nctId': 'NCT01325467', 'acronym': 'HyperQ', 'briefTitle': 'Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'BSP Biological Signal Processing Ltd.'}, 'officialTitle': 'Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry', 'orgStudyIdInfo': {'id': 'Clin_05_01'}}, 'contactsLocationsModule': {'locations': [{'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jo Anne Goldman, RT, RCIS, CCRC', 'role': 'CONTACT', 'email': 'JoAnne.Goldman@allina.com', 'phone': '612-863-3793'}, {'name': 'Rob Schwartz, MD', 'role': 'CONTACT', 'email': 'robert.Schwartz@allina.com', 'phone': '612-863-3823'}, {'name': 'Robert Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ritamarie F. Anselmo, BSN, RN', 'role': 'CONTACT', 'email': 'ANSELMR@CCF.org', 'phone': '216-444-9229'}, {'name': 'Cindy Stevenson, RN', 'role': 'CONTACT', 'email': 'stevenc@CCF.org', 'phone': '216-444-9417'}, {'name': 'Balaji Tamarappoo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James D. Thomas, MD, FACC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Bourque, MD', 'role': 'CONTACT', 'email': 'jbourque@virginia.edu', 'phone': '434-982-4661'}, {'name': 'Jayne Missel, RN BSN CCRC', 'role': 'CONTACT', 'email': 'JSM3S@hscmail.mcc.virginia.edu', 'phone': '434-243-7195'}, {'name': 'Jamieson Bourque, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Jamieson M Bourque, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Health System'}, {'name': 'Robert Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Heart Institute Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BSP Biological Signal Processing Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}