CancerAMICINCT04586894
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
An observational study of Cancer and Immune Defect, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immune Defect, Cardiovascular Abnormalities
- What is being tested?
- Cardiac MRI, Smart cloth and Biobanking
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2020to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing ICI therapy for cancer before the start of treatment.
Who may be able to join
- prescribed treatment by immune checkpoint inhibitors (ICI) for cancer
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4
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.
Read the detailed 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
- Conditions
- Cancer, Immune Defect, Cardiovascular Abnormalities
- Being tested
- Cardiac MRI, Smart cloth, Biobanking
- Keywords
- Cardiotoxicity, Immune checkpoint inhibitors, Cancer, Myocarditis, Pericarditis, Myositis, Thrombotic events
- Medical subject headings
- Neoplasms, Cardiovascular Abnormalities, Cardiotoxicity, Myocarditis, Pericarditis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Gadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy
Smart clothDevice
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.
BiobankingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Diagnostic Test: Cardiac MRI; Device: Smart cloth; Other: Biobanking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major cardiovascular advserse drug reactions
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.
Measured: 6 weeks
Secondary outcomes (5)
Number of patients with major cardiovascular advserse drug reactions
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.
Measured: 6 months
Number of patients with other cardiovascular advserse drug reactions
Incidence of a composite endpoint including vasculitis or myositis.
Measured: 6 weeks and 6 months
Number of patients with isolated CMR abnormalities
Serial assessment
Measured: 6 weeks and 6 months
Number of patients with rhythm abnormalities that do not fullfill major advsere event criteria
Burden of extrasystole, low degree conduction disorders
Measured: 6 weeks and 6 months
Risk factors for cardiovascular adverse drug event
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.
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start6 Nov 2020
- Primary completion1 Feb 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie, BioSerenity
- Responsible party
- Sponsor
- Investigators
- Mariana Mirabel, MD, Principal investigator, Inserm U970 Paris Cardiovascular Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586894
- Sponsor's protocol ID
- APHP191048
- Other IDs
- 2020-A01502-37
- Acronym
- AMICI
- Status last verified
- Jun 2023
- First submitted
- 7 Oct 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4
- ClinicalTrials.gov ID
- NCT04586894
- Acronym / sponsor ID
- AMICI / APHP191048
- Conditions
- Cancer, Immune Defect, Cardiovascular Abnormalities
- Keywords
- Cardiotoxicity, Immune checkpoint inhibitors, Cancer, Myocarditis, Pericarditis, Myositis, Thrombotic events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie, BioSerenity
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Cardiac MRI, Device: Smart cloth, Other: Biobanking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ICI therapy for cancer before the start of treatment.
Key inclusion criteria (1 listed)
- prescribed treatment by immune checkpoint inhibitors (ICI) for cancer
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIGadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy | Diagnostic test | Patients |
| Smart clothA 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. | Device | Patients |
| BiobankingBlood 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. | Other | Patients |
Primary outcome
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.
5 secondary outcomes
Number of patients with major cardiovascular advserse drug reactions
Time frame: 6 months
Number of patients with other cardiovascular advserse drug reactions
Time frame: 6 weeks and 6 months
Number of patients with isolated CMR abnormalities
Time frame: 6 weeks and 6 months
Number of patients with rhythm abnormalities that do not fullfill major advsere event criteria
Time frame: 6 weeks and 6 months
Risk factors for cardiovascular adverse drug event
Time frame: 6 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Mirabel, MD principal investigator
Inserm U970 Paris Cardiovascular Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Immune Defect, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with major cardiovascular advserse drug reactions (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.