Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors (AMICI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Cardiovascular Abnormalities; Immune Defect; Cancer

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04586894

2020-A01502-37 (Other Identifier)

APHP191048

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients

Treatment:

Device: Smart cloth

Other: Biobanking

Diagnostic Test: Cardiac MRI