Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-24 @ 10:37 PM
Study NCT ID:
NCT00991835
Status:
UNKNOWN
Last Update Posted:
2013-03-20
First Post:
2009-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plaque Registration and Event Detection In Computed Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-05-01', 'releaseDate': '2017-03-22'}, {'releaseDate': '2017-05-01', 'unreleaseDateUnknown': True}, {'resetDate': '2018-03-15', 'releaseDate': '2017-08-22'}, {'resetDate': '2019-01-17', 'releaseDate': '2018-08-08'}, {'resetDate': '2019-06-04', 'releaseDate': '2019-02-25'}, {'releaseDate': '2019-08-09', 'unreleaseDate': '2019-08-25'}, {'resetDate': '2019-09-25', 'releaseDate': '2019-08-25'}, {'resetDate': '2019-11-14', 'releaseDate': '2019-10-26'}], 'estimatedResultsFirstSubmitDate': '2017-03-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3015}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-18', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics', 'timeFrame': '2 years after CT'}], 'primaryOutcomes': [{'measure': 'Major cardiac events (Cardiac death and acute coronary syndrome)', 'timeFrame': '2 years after the CT-scan'}, {'measure': 'All-cause death', 'timeFrame': '2 years after the CT-scan'}], 'secondaryOutcomes': [{'measure': 'All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)', 'timeFrame': '2 years after CT-scan'}, {'measure': 'All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)', 'timeFrame': '2 years after the CT-scan'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Cardiovascular Diseases', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '24661823', 'type': 'DERIVED', 'citation': 'Yamamoto H, Awai K, Kuribayashi S, Kihara Y; PREDICT Investigators. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):90-6. doi: 10.1016/j.jcct.2013.12.004. Epub 2014 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients reffered to cardiovascular hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with known or suspected coronary artery disease.\n\nExclusion Criteria:\n\n* irregular heart beat,\n* known allergy towards the contrast agent,\n* renal dysfunction,\n* uncontrolled heart failure,\n* previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,\n* impossible breath-hold, OR\n* end-stage cancer.'}, 'identificationModule': {'nctId': 'NCT00991835', 'acronym': 'PREDICT', 'briefTitle': 'Plaque Registration and Event Detection In Computed Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University'}, 'officialTitle': 'Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography', 'orgStudyIdInfo': {'id': 'PREDICT2009'}}, 'contactsLocationsModule': {'locations': [{'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'overallOfficials': [{'name': 'Yasuki Kihara, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hiroshima University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences', 'investigatorFullName': 'Yasuki Kihara', 'investigatorAffiliation': 'Hiroshima University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-03-22', 'type': 'RELEASE'}, {'date': '2017-05-01', 'type': 'RESET'}, {'date': '2017-05-01', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-08-22', 'type': 'RELEASE'}, {'date': '2018-03-15', 'type': 'RESET'}, {'date': '2018-08-08', 'type': 'RELEASE'}, {'date': '2019-01-17', 'type': 'RESET'}, {'date': '2019-02-25', 'type': 'RELEASE'}, {'date': '2019-06-04', 'type': 'RESET'}, {'date': '2019-08-09', 'type': 'RELEASE'}, {'date': '2019-08-25', 'type': 'UNRELEASE'}, {'date': '2019-08-25', 'type': 'RELEASE'}, {'date': '2019-09-25', 'type': 'RESET'}, {'date': '2019-10-26', 'type': 'RELEASE'}, {'date': '2019-11-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yasuki Kihara, Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima University'}}}}