Skip to main content
OpenTrials
Completed

NCT Number: NCT04586894

Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Cardiomyopathies Cardiotoxicity Cardiovascular Abnormalities Cardiovascular Diseases Chemically-Induced Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Drug-Related Side Effects and Adverse Reactions Heart Diseases Immune Defect Muscular Diseases Musculoskeletal Diseases Myocarditis Myositis Neoplasms Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pericarditis Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP - Hôpital européen Georges-Pompidou

Paris, 75015, France

About this study

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.

Prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry.

The 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.

Mean 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.

4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are:

  • to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ICI,
  • to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ICI,
  • to bank cells to induce cardiomyocytes from stem cells
  • to bank DNA to identify genetic factors related to occurrence of cardiovascular events under ICI

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • current participation or exclusion period of another interventional clinical study

Exclusion criteria

for ancillary studies:

  • hemoglobinemia < 9 g/dl

Treatment and study plan

Cardiac MRI

Diagnostic Test

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

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.

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.

Primary outcomes

  1. Number of patients with major cardiovascular advserse drug reactions

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Number of patients with major cardiovascular advserse drug reactions

    Time frame: 6 months

    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.

  2. Number of patients with other cardiovascular advserse drug reactions

    Time frame: 6 weeks and 6 months

    Incidence of a composite endpoint including vasculitis or myositis.

  3. Number of patients with isolated CMR abnormalities

    Time frame: 6 weeks and 6 months

    Serial assessment

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

    Time frame: 6 weeks and 6 months

    Burden of extrasystole, low degree conduction disorders

  5. Risk factors for cardiovascular adverse drug event

    Time frame: 6 weeks and 6 months

    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.

Other outcomes

  1. Biomarkers level of heart failure

    Time frame: Baseline

  2. Cytokinic biomarkers level

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • BioSerenity
  • Fédération Française de Cardiologie

Registry information

Official study title

Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4

Acronym: AMICI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.