Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-18 @ 12:06 PM
Study NCT ID:
NCT07212751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary CT Angiogram - Prognostic Value of Adverse Plaque Features in Guiding Treatment (CT-PLAQUE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death and all-cause death', 'timeFrame': '5 years after CTCA examinations'}], 'secondaryOutcomes': [{'measure': 'Total plaque, total calcified plaque, total non-calcified plaque, CT-FFR', 'timeFrame': '5 years after CTCA examinations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTCA', 'CT', 'Coronary CT', 'Calcium Score', 'Plaque', 'Coronary Artery Disease', 'CAD', 'Chest pain', 'Patients with suspicion of coronary artery disease'], 'conditions': ['Determining if the Presence of Adverse Plaque Features Identified From the CT Angiogram Can Help Determining Prognosis and Guide Treatment Options']}, 'descriptionModule': {'briefSummary': 'The study aims at determining if the presence of adverse plaque features identified from the CT angiogram can help determine prognosis and guide treatment options.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '28000', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is ≥ 18 years old presented with chest pain and has undergone CTA between 01-Jan-2012 and 31-Dec-2022 before treatment\n* If multiple CTAs are taken, the most updated one before treatment commencement will be chosen.\n\nExclusion Criteria:\n\n* Patient who did not undergo cardiac CT scan due to inability to undergo cardiac CT scanning, kidney failure (serum creatinine \\>250 μmol/L or estimated glomerular filtration rate \\<30 mL/min), major allergy to contrast.'}, 'identificationModule': {'nctId': 'NCT07212751', 'acronym': 'CT-PLAQUE', 'briefTitle': 'Coronary CT Angiogram - Prognostic Value of Adverse Plaque Features in Guiding Treatment (CT-PLAQUE)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Coronary CT Angiogram - Prognostic Value of Adverse Plaque Features in Guiding Treatment (CT-PLAQUE)', 'orgStudyIdInfo': {'id': 'UW20-057'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient who is ≥ 18 years old presented with chest pain and has undergone CTA before treatment', 'interventionNames': ['Diagnostic Test: CTCA']}], 'interventions': [{'name': 'CTCA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient who is ≥ 18 years old presented with chest pain and has undergone CTA between 01-Jan-2012 and 31-Dec-2022 before treatment\n\n\\- If multiple CTAs are taken, the most updated one before treatment commencement will be chosen.', 'armGroupLabels': ['Patient who is ≥ 18 years old presented with chest pain and has undergone CTA before treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}