Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-31 @ 7:19 AM
Study NCT ID:
NCT00610766
Status:
COMPLETED
Last Update Posted:
2008-03-17
First Post:
2008-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1965}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-14', 'studyFirstSubmitDate': '2008-01-28', 'studyFirstSubmitQcDate': '2008-01-28', 'lastUpdatePostDateStruct': {'date': '2008-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation dose estimates of coronary MSCT angiography in daily practice', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems', 'timeFrame': '1 month'}, {'measure': "Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv", 'timeFrame': '1 month'}, {'measure': 'Assessment of potentials for additional dose savings (e.g. entire scan length; the distance between scan start to begin of coronary arteries and distance end of coronary arteries to end of scan)', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary CT angiography', 'radiation dose estimates'], 'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': 'Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in daily practice in an international, multicenter and vendor-independent trial.', 'detailedDescription': 'Prospective analysis of cardiac CT angiographies enrolled over 1 month\n\nCollection of 1 axial data set and the "patient dose protocol" (including kV, mAs, CTDI, DLP, etc.) on a CD\n\nDose estimation in dose/cm with the use of a method proposed by the European Working Group for Guidelines on Quality Criteria in CT.\n\nAssessment of diagnostic, qualitative image quality on a per-vessel basis by the participating study sites and in randomly selected cases by the primary study investigators (approximately 5-10% of patients to "spot check" interobserver variability of image quality assessments)\n\nAssessment of image quality with the use of quantitative parameters including image noise, signal-to-noise and contrast-to-noise ratios'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with indication for cardiac imaging by MSCT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* assessment of coronary arteries\n* acute chest pain or "triple rule out"\n* evaluation after PCI (stents)\n* evaluation of bypass grafts\n* before or after EP study\n* cardiac anomalies\n\nExclusion Criteria:\n\n* pregnancy\n* contraindications against contrast media'}, 'identificationModule': {'nctId': 'NCT00610766', 'acronym': 'PROTECTION-I', 'briefTitle': 'International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice', 'orgStudyIdInfo': {'id': 'GE IDE No. R00107'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Joerg Hausleiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PD Dr. Joerg Hausleiter', 'oldOrganization': 'Deutsches Herzzentrum'}}}}