Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05800093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proteomics and Genomics Combined With CT to Predict CVD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary Artery Disease Progression', 'timeFrame': 'Through study completion, between 130-156 weeks'}], 'secondaryOutcomes': [{'measure': 'Presence of obstructive stenosis', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Progression in number of significant (>50%) and severe (>70%) stenoses', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Total plaque volume progression', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Calcified plaque volume progression', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Non-calcified plaque volume progression', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Low-attenuation plaque volume progression', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Change in Pericoronary Adipose Tissue CT-Attenuation', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'CAD-RADS progression (yes/no)', 'timeFrame': 'Through study completion, between 130-156 weeks'}, {'measure': 'Progression in number of high-risk plaque characteristics (yes/no)', 'timeFrame': 'Through study completion, between 130-156 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease Progression']}, 'descriptionModule': {'briefSummary': 'This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients between 50 and 75 years old with nonobstructive coronary artery disease', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients between 50 and 75 years old\n* Subjects at intermediate to high risk for ASCVD\n* Asymptomatic patients without cardiac chest pain\n* Evidence of atherosclerosis on baseline CCTA\n\nExclusion Criteria:\n\n* Renal insufficiency, defined as eGFR \\< 30 ml/min\n* History of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke)\n* Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy\n* Change in lipid lowering therapy in the last 6 months\n* Use of more than two antihypertensive agents\n* No coronary atherosclerosis at baseline imaging\n* Active malignancy requiring treatment\n* Atrial fibrillation\n* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator\n* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.'}, 'identificationModule': {'nctId': 'NCT05800093', 'acronym': 'PREDICT-CVD', 'briefTitle': 'Proteomics and Genomics Combined With CT to Predict CVD', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Proteomics and Genomics Combined With CT to Predict CVD', 'orgStudyIdInfo': {'id': 'NL81913.018.22'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Erik SG Stroes, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'E.S.stroes', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}