Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 6:24 AM
Study NCT ID:
NCT06519292
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, serum and PBMC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Venous thromboembolism', 'timeFrame': '1 year, 5 years'}], 'primaryOutcomes': [{'measure': 'Non-calcified coronary plaque volume (difference between baseline and follow-up CT)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Plaque characteristics (differences between baseline and follow-up)', 'timeFrame': '1 year', 'description': 'Difference in plaque characteristics (i.e. fat attenuation index)'}, {'measure': 'Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up', 'timeFrame': '3 months, 1 year', 'description': 'Immune cell composition, T cell composition, IL-1b, IL-6, NLRP3, IL-17, TNF-a, IFN-y'}, {'measure': 'Incidence of Arterial thromboembolic event', 'timeFrame': '1 year, 5 years', 'description': 'Incidence of Arterial Thromboembolic events, defined as major cardiovascular events (MACE), including nonfatal ischemic stroke, nonfatal myocardial infarction and cardiovascular death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immune checkpoint inhibitors', 'cardiovascular disease', 'atherosclerosis'], 'conditions': ['Cardiovascular Diseases', 'Arterial Thrombosis', 'Myocardial Infarction', 'Stroke', 'Coronary Artery Disease', 'Atherosclerosis', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment and are now approved for various types of cancer. The most common side effects of ICI are immune-related adverse events which can affect any organ or system in the body. Recently, concerns have also risen about cardiovascular effects of ICI. Retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event.\n\nThe mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke, are unclear. Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI, immune-related hypercoagulability or (autoimmune) antiphospholipid antibodies may play a role, but data to support this are lacking. The longer-term risk of arterial thromboembolism may be predominantly driven by (accelerated) atherosclerosis, a chronic low-grade inflammatory disease of the larger arteries. Therefore, this study evaluates the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male or female subjects are eligible for study participation if they have a confirmed cancer diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed diagnosis of the following tumor types, any stage: esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma, renal cell carcinoma\n* Prior to start of new therapy (i.e. immune checkpoint inhibitor, chemotherapy or follow-up in case of esophageal cancer)\n* Age ≥ 50 years\n\nExclusion Criteria:\n\n* ICI therapy in previous 12 months\n* Suspected or confirmed viral, fungal, or bacterial infectious disease\n* Use of immunosuppressive therapy prior to ICI start\n* Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m2\n* Known allergy to iodinated contrast agents\n* Atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT06519292', 'acronym': 'ITHACA', 'briefTitle': 'Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer', 'orgStudyIdInfo': {'id': 'NL82446.018.22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICI group', 'description': 'Patients that receive immune checkpoint inhibitors', 'interventionNames': ['Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline', 'Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year']}, {'label': 'Non-ICI group', 'description': 'Patients with similar malignancies, who do not receive immune checkpoint inhibitors', 'interventionNames': ['Diagnostic Test: Coronary computed tomography angiography (CCTA) at baseline', 'Diagnostic Test: Coronary computed tomography angiography (CCTA) after 1 year']}], 'interventions': [{'name': 'Coronary computed tomography angiography (CCTA) at baseline', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detailed imaging of coronary arteries', 'armGroupLabels': ['ICI group', 'Non-ICI group']}, {'name': 'Coronary computed tomography angiography (CCTA) after 1 year', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detailed imaging of coronary arteries', 'armGroupLabels': ['ICI group', 'Non-ICI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'A Strijdhorst', 'role': 'CONTACT', 'email': 'a.strijdhorst@amsterdamumc.nl', 'phone': '+31 205665975'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'A Strijdhorst', 'role': 'CONTACT', 'email': 'a.strijdhorst@amsterdamumc.nl', 'phone': '+31 205665975'}], 'overallOfficials': [{'name': 'H.W.M. van Laarhoven, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'secretariaat.oncologie@amsterdamumc.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanneke W. M. van Laarhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amsterdam UMC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hanneke W. M. van Laarhoven', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}