Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

NCT04586894 | Completed

• 2 other identifiers: APHP1910482020-A01502-37
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Immune Defect; Cardiovascular Abnormalities

Keywords

Cardiotoxicity; Immune checkpoint inhibitors; Cancer; Myocarditis; Pericarditis; Myositis; Thrombotic events

Outcome Measures

Primary Outcomes (1)

• Number of patients with major cardiovascular advserse drug reactions

  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.

  6 weeks

Secondary Outcomes (5)

• Number of patients with major cardiovascular advserse drug reactions

  6 months

• Number of patients with other cardiovascular advserse drug reactions

  6 weeks and 6 months

• Number of patients with isolated CMR abnormalities

  6 weeks and 6 months

• Number of patients with rhythm abnormalities that do not fullfill major advsere event criteria

  6 weeks and 6 months

• Risk factors for cardiovascular adverse drug event

  6 weeks and 6 months

Other Outcomes (2)

• Biomarkers level of heart failure

  Baseline

• Cytokinic biomarkers level

  Baseline

Study Arms (1)

Patients

Diagnostic Test: Cardiac MRI; Device: Smart cloth; Other: Biobanking

Interventions

Cardiac MRI DIAGNOSTIC_TEST

Gadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy

Patients

Smart cloth DEVICE

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.

Patients

Biobanking OTHER

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ICI therapy for cancer before the start of treatment.

You may qualify if:

• \- prescribed treatment by immune checkpoint inhibitors (ICI) for cancer

You may not qualify if:

• previous treatment by any ICI
• any contraindication to cardiac resonance magnetic imaging
• contraindication to gadoteric acid, meglumin or any gadolinium-based contrast agent
• pace maker or automated implantable defibrilator
• pregnancy, breastfeeding
• 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
• patient under legal protection
• renal failure defined by creatinine clearance \<30ml/min/m² (CKD-EPI)
• \- hemoglobinemia \< 9 g/dl

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fédération Française de Cardiologie: collaborator
• BioSerenity: collaborator

Study Sites (1)

AP-HP - Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Neoplasms; Cardiovascular Abnormalities; Cardiotoxicity; Myocarditis; Pericarditis; Myositis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Cardiomyopathies; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mariana Mirabel, MD

  Inserm U970 Paris Cardiovascular Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: November 6, 2020
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: 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. Teams 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).

Locations

FR (1)