Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT06187532
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carotid Plaque-Burden Scale and Outcomes. A Real Life Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in rates of major adverse cardiovascular events (MACE)', 'timeFrame': '12 year follow-up', 'description': 'MACE: number of Major Adverse Cardiovascular Events; myocardial infarction, ictus or amputation or revascularisation of leg due to critical ischaemia'}, {'measure': 'Differences in rates of all-cause death', 'timeFrame': '12 year follow-up', 'description': 'All-cause death: number of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Diagnostic value of Carotid Plaque-Burden-Systematic COronary Risk EvaluationSystematic COronary Risk Evaluation2 (CPB-SCORE2) table compared to Systematic COronary Risk Evaluation2 (SCORE2) for MACE', 'timeFrame': '12 year follow-up', 'description': 'Minimum and maximum values are 1 and 3, were higher scores mean a worse outcome. Sensitivity, Specificity, negative predictive value; positive likelihood ratio; negative likelihood ratio (%). net reclassification index;will be compared between High-Risk vs Low-Intermediate-Risk to PBS-SCORE2 table compared SCORE2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carotid ultrasound.', 'Carotid plaque-burden', 'atheroscleroses events prediction'], 'conditions': ['Atheroscleroses, Cerebral', 'Carotid Plaque']}, 'descriptionModule': {'briefSummary': 'Carotid ultrasonography has been proposed as a tool for prediction of future cardiovascular disease (CVD). Nevertheless, its role in clinical practice remains controversial.\n\nMethods: The investigators analyse the incidence of CVD and mortality in a cohort of 1004 participants without preexisting CVD according to a simple plaque scale recorded in different segments of the carotid artery assess by ultrasound. A prognostic tool for CV events was development adding Carotid Plaque-Burden (CPB) scale to the Systematic COronary Risk Evaluation (SCORE2) table (CPB- SCORE2 scale).', 'detailedDescription': 'Based in number of plaques and stenosis a simple plaque scale was recorded in different segments of carotid artery, involving a cohort of 1004 participants with vascular risk factors. Outcomes were recorded during 14 years. A prognostic tool for CV events was development adding simple Carotid Plaque-Burden (CPB) scale to the SCORE2 table (CPB- SCORE2 scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a major vascular risk factor, hypertension, diabetes or hypercholesterolemia, from vascular risk office at the Hospital Universitario San Pedro de Alcántara, Cáceres, Spain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any of these vascular risk factors: Total cholesterol \\>200 mg/dL, hypertension, or diabetes, or receiving medication for them\n* No cardiovascular disease: coronary, cerebral o peripheral arterial disease.\n\nExclusion Criteria:\n\n* Associated conditions: cancer, heart failure, chronic obstructive disease, renal insufficiency, neurodegenerative diseases, rheumatic diseases or chronic infections.\n* Neck anatomical barriers to perform ultrasound.\n* Enrolled in a clinical trial.\n* Attend \\<70% of regular appointments'}, 'identificationModule': {'nctId': 'NCT06187532', 'briefTitle': 'Carotid Plaque-Burden Scale and Outcomes. A Real Life Study', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura'}, 'officialTitle': 'Carotid Plaque-Burden Scale and Outcomes. Improvements in Risk Stratification for Future Cardiovascular Disease by Adding to SCORE2. A Real Life Study', 'orgStudyIdInfo': {'id': '1122023'}, 'secondaryIdInfos': [{'id': '11223', 'type': 'OTHER', 'domain': 'FUNDESALUD'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'JUAN SANCHEZ M-TORRERO, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Extremadura'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}