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Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

NCT04586894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-06-08

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Cardiac MRI

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

DEVICE

Smart cloth

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.

OTHER

Biobanking

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.

Sponsors & Collaborators

  • Fédération Française de Cardiologie

    collaborator OTHER

  • BioSerenity

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Mariana Mirabel, MD · Inserm U970 Paris Cardiovascular Research Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2022-02-01
Completion
2022-07-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586894 on ClinicalTrials.gov