Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT07220304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-23
First Post:
2025-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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', 'maskingDescription': 'Open-label study. Both investigators and participants are aware of CaRi-Heart® analysis results.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm prospective diagnostic study evaluating the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for suspected or known coronary artery disease'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2025-10-22', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical management decisions following CaRi-Heart® analysis', 'timeFrame': 'Up to 60 days following CCTA completion', 'description': 'The proportion of patients for whom the addition of CaRi-Heart® analysis to standard Coronary CT Angiography (CCTA) results in a change in clinical management decisions, such as initiation or adjustment of preventive therapies (e.g., statins, antiplatelet agents, lifestyle modification, or cardiology referral).\n\nManagement decisions before and after reviewing CaRi-Heart® results will be compared to quantify impact on diagnostic interpretation and treatment planning'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CaRi-Heart', 'Coronary CT Angiography (CCTA)', 'AI Cardiac Imaging', 'Coronary Inflammation', 'Cardiovascular Risk Stratification', 'Plaque Characterization', 'Community-Based Imaging', 'Noninvasive Cardiac Diagnostics', 'Artificial Intelligence in Cardiology'], 'conditions': ['Coronary Artery Disease', 'Atherosclerosis', 'Cardiovascular Inflammation']}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard Coronary CT Angiography (CCTA) exam. The goal is to determine whether the additional information provided by CaRi-Heart® changes clinical decision-making and helps improve early identification and management of coronary artery disease in community imaging centers. Patients who undergo CCTA as part of their regular care will be invited to have their scans analyzed using CaRi-Heart® at no extra cost, time, or radiation.', 'detailedDescription': 'This is a prospective, community-based interventional study designed to assess the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for evaluation of suspected or known coronary artery disease.\n\nCaRi-Heart® is a software-as-a-medical-device (SaMD) that uses advanced AI algorithms to quantify coronary inflammation and generate a CaRi-Heart® Risk Score from existing CCTA images. The analysis provides color-coded visualization and quantitative metrics that may improve risk stratification beyond traditional plaque and stenosis assessment.\n\nThe study aims to compare management decisions made before and after review of the CaRi-Heart® analysis, measuring how often the additional information influences diagnostic interpretation or changes treatment recommendations (such as preventive therapy or referral).\n\nApproximately 15,000 participants will be enrolled across multiple outpatient imaging centers in Michigan. All data will be collected under standard clinical workflows with IRB approval, informed consent, and HIPAA compliance. No additional scanning, contrast, or radiation exposure will occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinically indicated CCTA undertaken for evaluation of coronary artery disease.\n2. Ability to provide written informed consent\n3. Patient between 18 and 80 years old\n\nExclusion Criteria:\n\n\\- 1. History of surgical revascularization (coronary artery bypass graft, CABG) 2. CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR) 3. The CCTA is of poor quality or partly unanalysable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.\n\n4\\. Inability to provide required health information 5. Pregnancy or any known contraindication for CCTA'}, 'identificationModule': {'nctId': 'NCT07220304', 'acronym': 'CARE-CCTA', 'briefTitle': 'CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)', 'organization': {'class': 'OTHER', 'fullName': 'Corazon Medical PC'}, 'officialTitle': 'CaRi-Heart® Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA): A Prospective U.S. Community-Based Study on the Impact of CaRi-Heart® Analysis in Patients Undergoing CCTA for Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'CARE-CCTA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CaRi-Heart® Analysis Group', 'description': 'Participants receiving standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making.', 'interventionNames': ['Device: CaRi-Heart® Analysis']}], 'interventions': [{'name': 'CaRi-Heart® Analysis', 'type': 'DEVICE', 'otherNames': ['AI-based coronary inflammation analysis', 'CaRi-Heart Risk Score'], 'description': 'CaRi-Heart® is an artificial-intelligence-based software device that analyzes coronary CT angiography (CCTA) images to quantify coronary inflammation and generate a CaRi-Heart Risk Score. The analysis provides color-coded visualization and quantitative metrics derived from perivascular fat tissue characteristics, enabling improved assessment of coronary artery disease risk.\n\nIn this study, CaRi-Heart® analysis is applied prospectively to CCTA images obtained as part of standard clinical care. The results are reviewed by the interpreting physician and recorded to determine whether the additional information affects diagnostic interpretation or management decisions. No additional imaging, radiation, or contrast exposure occurs.', 'armGroupLabels': ['CaRi-Heart® Analysis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48124', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'JOSH KATKE, MHSA', 'role': 'CONTACT', 'email': 'JKATKE@CORAZONIMAGING.COM'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48072', 'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'JOSH KATKE, MHSA', 'role': 'CONTACT', 'email': 'JKATKE@CORAZONIMAGING.COM'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'zip': '48723', 'city': 'Caro', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'JOSH KATKE, MHSA', 'role': 'CONTACT', 'email': 'JKATKE@CORAZONIMAGING.COM'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 43.49073, 'lon': -83.39885}}, {'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'JOSH KATKE, MHSA', 'role': 'CONTACT', 'email': 'JKATKE@CORAZONIMAGING.COM', 'phone': '2482298285'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48532', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'JOSH KATKE, MHSA', 'role': 'CONTACT', 'email': 'JKATKE@CORAZONIMAGING.COM'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48154', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '48044', 'city': 'Macomb', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.70087, 'lon': -82.95909}}, {'zip': '48071', 'city': 'Madison Heights', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.48587, 'lon': -83.1052}}, {'zip': '48858', 'city': 'Mount Pleasant', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 43.59781, 'lon': -84.76751}}, {'zip': '48377', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '48603', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48080', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '48310', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '48183', 'city': 'Trenton', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.13949, 'lon': -83.17826}}, {'zip': '48327', 'city': 'Waterford', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 42.69303, 'lon': -83.41181}}, {'zip': '17022', 'city': 'Elizabethtown', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'JOSH KATKE, MHSA', 'role': 'CONTACT', 'email': 'JKATKE@CORAZONIMAGING.COM'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 40.15287, 'lon': -76.60275}}, {'zip': '17043', 'city': 'Lemoyne', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}, {'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com'}], 'facility': 'Corazon Imaging', 'geoPoint': {'lat': 40.2412, 'lon': -76.89414}}], 'centralContacts': [{'name': 'HOUDA ABDALLAH, msn', 'role': 'CONTACT', 'email': 'habdallah@corazonimaging.com', 'phone': '3136587778'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified individual participant data (IPD) may be shared with qualified researchers upon reasonable request after study completion, subject to IRB approval, institutional policies, and a data-use agreement. Data elements may include demographic variables, CaRi-Heart® risk scores, and CCTA-derived imaging metrics. No protected health information (PHI) will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corazon Medical PC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}