Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 5:14 PM
Study NCT ID:
NCT06986733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prevalence of MACE in population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score < 75th centile)', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'A comparison of the number of major adverse cardiac events (MACE) in the population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score \\< 75th centile)'}], 'primaryOutcomes': [{'measure': 'To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The percentage of patients who received a change in recommended clinical management following review of their CaRi-Heart analysis.'}], 'secondaryOutcomes': [{'measure': 'To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The percentage of patients reclassified into a higher (or lower) risk category using the CaRi-Heart® based AI-Risk classification, when compared to standard clinical risk assessment tools (i.e., ASCVD-PCE).'}, {'measure': 'Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The percentage patients who have FAI-Score above the 75th percentile.'}, {'measure': "Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).", 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The percentage patients with a CADRADs score of 0-1, who have FAI-Score above the 75th percentile.'}, {'measure': 'Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The percentage patients who have FAI-Score above the 75th percentile in each of the following sub-groups: geographical location, patient age, patient sex, patient ancestry.'}, {'measure': 'Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The correlation coefficient for FAI-Score versus other available diagnostic test results (e.g., hsCRP, CACS etc.).'}, {'measure': 'Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)', 'timeFrame': 'Two weeks from initial review to review with CaRi-Heart results', 'description': 'The correlation coefficient for FAI-Score versus the quantitative plaque metrics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the CaRi-Heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any participant who has had a clinically indicated analysable CCTA at the three hospital collaborators', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically indicated CCTA undertaken for evaluation of coronary artery disease.\n\nExclusion Criteria:\n\n* History of surgical revascularization (coronary artery bypass graft, CABG)\n* CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)\n* The CCTA is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.'}, 'identificationModule': {'nctId': 'NCT06986733', 'acronym': 'SMART-CCTA-1', 'briefTitle': 'Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Caristo Diagnostics Limited'}, 'officialTitle': 'Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study', 'orgStudyIdInfo': {'id': 'SMART-CCTA-1'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caristo Diagnostics Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arkansas Cardiology, P.A.', 'class': 'NETWORK'}, {'name': 'Baptist Health, Louisville', 'class': 'OTHER'}, {'name': 'Northeast Georgia Hospital System', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}