Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-26 @ 4:42 PM
Study NCT ID:
NCT04586894
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D009205', 'term': 'Myocarditis'}, {'id': 'D010493', 'term': 'Pericarditis'}, {'id': 'D009220', 'term': 'Myositis'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarkers level of heart failure', 'timeFrame': 'Baseline'}, {'measure': 'Cytokinic biomarkers level', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Number of patients with major cardiovascular advserse drug reactions', 'timeFrame': '6 weeks', 'description': 'Incidence of a composite endpoint including myocarditis, pericarditis, acute coronary syndrome, acute heart failure, subclinial cardio-toxicity, high degree conduction abormalities or ventricular sustained arrythmias, cardiovascular death.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with major cardiovascular advserse drug reactions', 'timeFrame': '6 months', 'description': 'Incidence of a composite endpoint including myocarditis, pericarditis, acute coronary syndrome, acute heart failure, subclinial cardio-toxicity, high degree conduction abormalities or ventricular sustained arrythmias, cardiovascular death.'}, {'measure': 'Number of patients with other cardiovascular advserse drug reactions', 'timeFrame': '6 weeks and 6 months', 'description': 'Incidence of a composite endpoint including vasculitis or myositis.'}, {'measure': 'Number of patients with isolated CMR abnormalities', 'timeFrame': '6 weeks and 6 months', 'description': 'Serial assessment'}, {'measure': 'Number of patients with rhythm abnormalities that do not fullfill major advsere event criteria', 'timeFrame': '6 weeks and 6 months', 'description': 'Burden of extrasystole, low degree conduction disorders'}, {'measure': 'Risk factors for cardiovascular adverse drug event', 'timeFrame': '6 weeks and 6 months', 'description': 'Characterization of risk predictors for occurrence of cardiovascular adverse drug event, among the following: socio-demographic characteristics, oncologic characteristics, previous treatments, serum biomarkers, patient assessment on ESC-SCORE and ACC/AHA ASCVD risk scoring systems, immune status, cardiac characteristics on imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiotoxicity', 'Immune checkpoint inhibitors', 'Cancer', 'Myocarditis', 'Pericarditis', 'Myositis', 'Thrombotic events'], 'conditions': ['Cancer', 'Immune Defect', 'Cardiovascular Abnormalities']}, 'descriptionModule': {'briefSummary': 'Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.', 'detailedDescription': "Immune checkpoint inhibitors (ICIs) are drastically improving cancer prognosis. Cardiovascular adverse side effects of ICIs are though to be rare but may be responsible for \\~50% death rates.\n\nProspective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry.\n\nThe aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ICI therapy for cancer. Biomarkers as ECG, echocardiography, cardiac magnetic resonance imaging and long-term ECG monitoring will be undertaken at inclusion (before ICI therapy is started), and during the first cycle treatments and at 6 months follow-up.\n\nMean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ICI cycle. Secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects.\n\n4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are:\n\n* to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ICI,\n* to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ICI,\n* to bank cells to induce cardiomyocytes from stem cells\n* to bank DNA to identify genetic factors related to occurrence of cardiovascular events under ICI"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing ICI therapy for cancer before the start of treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- prescribed treatment by immune checkpoint inhibitors (ICI) for cancer\n\nExclusion Criteria:\n\n* previous treatment by any ICI\n* any contraindication to cardiac resonance magnetic imaging\n* contraindication to gadoteric acid, meglumin or any gadolinium-based contrast agent\n* pace maker or automated implantable defibrilator\n* pregnancy, breastfeeding\n* women of childbearing potential who do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion\n* patient under legal protection\n* renal failure defined by creatinine clearance \\<30ml/min/m² (CKD-EPI)\n* current participation or exclusion period of another interventional clinical study\n\nExclusion Criteria for ancillary studies:\n\n\\- hemoglobinemia \\< 9 g/dl'}, 'identificationModule': {'nctId': 'NCT04586894', 'acronym': 'AMICI', 'briefTitle': 'Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4', 'orgStudyIdInfo': {'id': 'APHP191048'}, 'secondaryIdInfos': [{'id': '2020-A01502-37', 'type': 'OTHER', 'domain': 'Agence nationale de sécurité du médicament et des produits de santé'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'interventionNames': ['Diagnostic Test: Cardiac MRI', 'Device: Smart cloth', 'Other: Biobanking']}], 'interventions': [{'name': 'Cardiac MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy', 'armGroupLabels': ['Patients']}, {'name': 'Smart cloth', 'type': 'DEVICE', 'description': 'A smart cloth recording cardiac and hemodynamic parameters will be worn by patients during 42 days. Replaced by a holter monitor if the smart cloth is refused or not tolerated by the patient.', 'armGroupLabels': ['Patients']}, {'name': 'Biobanking', 'type': 'OTHER', 'description': 'Blood samples (plasma, serum, DNA, stem cells, immune cells) taken as part of the study will be stored in a biological sample collection. These samples may be used for further analysis not described in the initial protocol but which may be useful for investigation or in light of advances in scientific knowledge.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital européen Georges-Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Mariana Mirabel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inserm U970 Paris Cardiovascular Research Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.\n\nTeams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fédération Française de Cardiologie', 'class': 'OTHER'}, {'name': 'BioSerenity', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}