Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-06

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cancer Immune Defect Cardiovascular Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

Smart cloth

Intervention Type 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

Intervention Type 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.

Interventions

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Cardiac MRI

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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

\- hemoglobinemia \< 9 g/dl

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No