Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy (MEDIIMYO)
Primary Purpose
Myocarditis
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional time for the MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocarditis focused on measuring anti-cancer immunotherapy, cardiac autoimmune diseases, Myocarditis
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or other cardiovascular complications
- Patient over 18 years of age
- Patient affiliated to a health insurance plan
- Patient who has given free, informed and oral consent
Exclusion Criteria:
- Contraindication to immunotherapy
- Pregnant or breastfeeding patient (if applicable)
- Contraindication to cardiac MRI
Sites / Locations
- Centre Chirurgical Marie Lannelongue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient undergoing immunotherapy with an indication for cardiac MRI
Arm Description
Patient undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or myocarditis or other cardiovascular complications
Outcomes
Primary Outcome Measures
cardiac MRI
ejection fraction
Secondary Outcome Measures
Full Information
NCT ID
NCT05125965
First Posted
November 2, 2021
Last Updated
November 17, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT05125965
Brief Title
Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy
Acronym
MEDIIMYO
Official Title
Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected.
Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated.
In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%.
In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis
Keywords
anti-cancer immunotherapy, cardiac autoimmune diseases, Myocarditis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient undergoing immunotherapy with an indication for cardiac MRI
Arm Type
Experimental
Arm Description
Patient undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or myocarditis or other cardiovascular complications
Intervention Type
Other
Intervention Name(s)
additional time for the MRI
Intervention Description
3 additional minutes to perform the MRI
Primary Outcome Measure Information:
Title
cardiac MRI
Description
ejection fraction
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or other cardiovascular complications
Patient over 18 years of age
Patient affiliated to a health insurance plan
Patient who has given free, informed and oral consent
Exclusion Criteria:
Contraindication to immunotherapy
Pregnant or breastfeeding patient (if applicable)
Contraindication to cardiac MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arshid Azarine, MD
Phone
01.40.94.27.17
Email
aazarine@ghpsj.fr
Facility Information:
Facility Name
Centre Chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
92350
Country
France
12. IPD Sharing Statement
Learn more about this trial
Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy
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