Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors (AMICI)
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|ClinicalTrials.gov Identifier: NCT04586894|
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment|
|Cancer Immune Defect Cardiovascular Abnormalities||Diagnostic Test: Cardiac MRI Device: Smart cloth Other: Biobanking|
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
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||April 2022|
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
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.
- 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.
- 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.
- 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.
- Number of patients with isolated CMR abnormalities [ Time Frame: 6 weeks and 6 months ]Serial assessment
- 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
- 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.
- Biomarkers level of heart failure [ Time Frame: Baseline ]
- Cytokinic biomarkers level [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586894
|Contact: Aurélie Guimfackfirstname.lastname@example.org|
|Contact: Yvann Frigoutemail@example.com|
|AP-HP - hôpital européen Georges-Pompidou|
|Paris, France, 75015|
|Principal Investigator:||Mariana Mirabel, MD||Assistance Publique - Hôpitaux de Paris|