Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03018834
Eligibility Criteria:
Inclusion Criteria:
* Patients hospitalized for Acute myocarditis defined as:
* Chest Pain (or modification of the ECG) AND Troponin Rise (\*1.5 Normal range) AND Myocarditis proven by MRI in the first 72h after admission
* Age \> 18 and \<65 years old
* Accepting effective contraception during treatment duration (men and women childbearing potential)
* Signed informed consent Normal Coronary angiography or coronary CT Scan (made during the previous year is acceptable) (normal is defined as stenosis \< 50%) (In the case of patients under 40 with typical MRI of myocarditis, coronary angiography is not mandatory and left to the doctor's discretion)
Exclusion Criteria:
* Active coronary disease
* Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipid antibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis, giant cell myocarditis, treated chronic inflammatory disease, tuberculosis, HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV), Hepatitis B virus (HBV) infection,
* Latex allergy
* Pregnancy, breastfeeding
* Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients, neutropenia \< 1,5.10\^9/L)
* Renal failure, Creatine Clearance (CrCl) \< 30 ml/min (MDRD)
* Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
* History of malignancy
* Non Steroidian Anti Inflammatory drug within the past 14 days
* Anti Tumor Necrosis Factor (TNF) within the past 14 days
* No affiliation to the French Health Care System "sécurité sociale"
* Hepatic impairment = Child-Pugh Class C
* Mechanical ventilation
* Circulatory assistance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03018834
Study Brief:
Protocol Section:
NCT03018834