Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-01 @ 5:03 AM
Study NCT ID:
NCT02303067
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2014-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08-13', 'completionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary substraction CCTA improves the diagnostic accuracy.', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['Cardiac', 'Computed Tomography', 'Coronary Artery Disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Background:\n\n\\- This study is designed for people who need a standard, non-research invasive coronary angiogram to find out if they have heart disease. Researchers want to take a computed tomography (CT) scan of people s hearts before their procedure to see if this less invasive test can also diagnose coronary artery disease.\n\nObjectives:\n\n\\- To learn if a new way to view CT pictures is able to accurately diagnose coronary artery disease.\n\nEligibility:\n\n\\- People age 55 and older who need a coronary angiogram.\n\nDesign:\n\n* Participants will be screened with their medical records.\n* Participants may give a blood sample.\n* Participants may have a CT scan of the heart with and without contrast. The CT scan will not interfere with their medical care.\n* Participants blood pressure and heart rhythm will be monitored before, during, and after the CT scan. They may have an electrocardiogram.\n* Before the scan, participants will have an intravenous catheter put into their arm. It will be used to inject contrast.\n* Participants may take a beta blocker to slow their heart rate.\n* Participants may take nitroglycerin under their tongue. It will enlarge their heart blood vessels and improve picture quality. It may cause a flushing sensation or headache.\n* Participants will lie on their back on a padded table. The table slides into a large, donut-shaped machine. An x-ray tube will move around their body, taking pictures. They will be asked to hold their breath for 5 seconds at a time.\n* Participants will be called 30 days after their angiogram. They will answer questions about their health, hospital visits, or medical treatments.', 'detailedDescription': 'Coronary calcium can impair the accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction, where areas of calcification identified on a non-contrast scan are removed from the contrast enhanced images.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\n 1. Age over 55 years\n 2. Subjects referred for coronary angiography\n 3. Able to understand and willing to sign the Informed Consent Form\n\nEXCLUSION CRITERIA:\n\n1. Known allergy to iodinated contrast media\n2. Estimated GFR less than 50 ml/min\n3. Atrial fibrillation or other continuous cardiac arrhythmias\n4. Known or suspected intolerance or contraindication to beta-blocker medication (i.e. significant reactive airway disease, decompensated heart failure, Mobitz type 2 second degree or 3rd degree atrio-ventricular heart block)\n5. Inability to adequately hold breath for 5 seconds\n6. Pregnancy. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.'}, 'identificationModule': {'nctId': 'NCT02303067', 'briefTitle': 'Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Prospective International Study of Coronary Subtraction Using 320 Row-Detector CT', 'orgStudyIdInfo': {'id': '150026'}, 'secondaryIdInfos': [{'id': '15-H-0026'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Marcus Y Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}