Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-26 @ 4:42 PM
Study NCT ID:
NCT04586894
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMICI
Brief 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). 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A01502-37 | OTHER | Agence nationale de sécurité du médicament et des produits de santé | View |