Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT04564794
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Cardial Stress Perfusion Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11952}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall mortality', 'timeFrame': '6 months', 'description': 'to evaluate the prognostic contribution of low radiation stress myocardial perfusion scintigraphy on overall mortality risk , overall mortality will be calculate'}], 'secondaryOutcomes': [{'measure': 'Death from cardiac causes, either proven or suspected (death from unexplained causes),', 'timeFrame': '6 months', 'description': 'To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on mortality from cardiac causes.'}, {'measure': 'Major cardiac events (death of proven or suspected cardiac cause, myocardial infarction, myocardial revascularization procedure),', 'timeFrame': '6 months', 'description': 'To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on major cardiac events'}, {'measure': 'Cardiac mortality and major cardiac events.', 'timeFrame': '6 months', 'description': 'To evaluate the prognostic contribution of myocardial perfusion scintigraphy of low radiation stress on quality of examination complementary to coronary angiography in a subgroup of approximately 700 patients who had a coronary angiography within ≤ 2 months compared to scintigraphy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary', 'myocardial perfusion tomoscintigraphy.'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices.\n\nToday, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments.\n\nThe implications are unknown in terms of the risk of death of the different parameters studied', 'detailedDescription': 'Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices (medical treatment, myocardial revascularization, ...). The arrival of new solid-state cameras has been a real technological leap for this examination, making it possible to significantly improve the quality of the images and also to drastically reduce the activities of injected radiopharmaceuticals and thus the exposure of patients and staff to ionizing radiation. Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments. The injected activities are reduced up to a third of those injected in the past (this is indeed the case in the population we propose to study).\n\nHowever, the value of the prognostic stratification obtained with stress myocardial perfusion scans recorded with low activity on semiconductor cameras is not yet known. In particular, the implications are unknown in terms of the risk of death of the different parameters studied (normal or abnormal examination, extent of myocardial ischemia and infarction sequelae, impact on left ventricular function in post-stress and resting states, etc.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any coronary patient suspected or proven to have had a stress myocardial perfusion tomoscintigraphy performed at the Nancy CHRU and corresponding to a standardized model of expression of results (i.e. more than 10,000 reports).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any coronary patient suspected or proven to have had a stress myocardial perfusion tomoscintigraphy performed at the Nancy CHRU and corresponding to a standardized model of expression of results (i.e. more than 10,000 reports).\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04564794', 'acronym': 'PROSPERCARS', 'briefTitle': 'Prognostic Value of Cardial Stress Perfusion Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans', 'orgStudyIdInfo': {'id': '2020PI174'}}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Grand Est', 'country': 'France', 'facility': 'Nancy Hospital', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Pierre-Yves Marie, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nancy CHRU hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical director', 'investigatorFullName': 'Pierre Yves MARIE', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}