Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT05536960
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2022-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in TBRmax', 'timeFrame': '1 day', 'description': 'Difference of target to background ratio (TBR)max in the coronary arteries between groups.'}], 'secondaryOutcomes': [{'measure': 'Correlation between TBRmax and FAI.', 'timeFrame': '1 day', 'description': 'Correlation of TBRmax with fat attenuation index, a specific CCTA parameter of vascular inflammation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atheroscleroses, Coronary']}, 'descriptionModule': {'briefSummary': 'To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 50 years and older\n* Underwent CCTA imaging within 78 weeks from the screening visit\n* Either CAD-RADS 4 or higher or 0/1 on CCTA.\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \\< 45 ml/min/1,73m2.\n* CVD events/revascularization in history\n* Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.\n* Chronic or recent (\\< 1 month) infections and/or clinical signs of acute infection.\n* History of auto-immune diseases.\n* Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.\n* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.\n* Elevated liver enzymes (\\> 2 ULN of liver transaminases), acute liver failure or known liver disease.'}, 'identificationModule': {'nctId': 'NCT05536960', 'acronym': 'DOLPHIN', 'briefTitle': 'Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction', 'orgStudyIdInfo': {'id': 'NL80263.018.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-Dotatate PET/CT', 'description': 'These patients will undergo a 68Ga-Dotatate PET/CT scan.', 'interventionNames': ['Other: 68Ga-Dotatate PET/CT']}], 'interventions': [{'name': '68Ga-Dotatate PET/CT', 'type': 'OTHER', 'description': 'One 68Ga-Dotatate PET/CT to determine uptake of tracer in the arterial wall.', 'armGroupLabels': ['68Ga-Dotatate PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'E.S.stroes', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}