infectious myocarditis
Conditions
Interventions
Trade Name: SOMAKIT TOC 40 microgrammes
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Sponsors
CHRU DE NANCY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Major patient having received complete information on the organization of the research and having signed their informed consent. - Patient hospitalized for chest pain with positive troponins, - Patient with a high probability of acute inflammatory myocarditis on secondary MRI (= 2 Lake Louise criteria) - Person affiliated with or benefiting from a social security scheme. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Patient with history of heart disease - Patient with coronary stenosis of more than 50% on coronary angiography or CT - Patient with a formal or relative contraindication for performing a PET / CT scan at 68Ga DOTATOC - Impossibility of performing a PET scan at 68Ga-DOTATOC (agitated, confused patient ...). Unable to schedule the PET / CT exam at 68Ga-DOTATOC within a maximum of 72 hours after the MRI. - Patient currently being treated with corticosteroids prior to the 68Ga-DOTATOC PET / CT examination. - Patient treated with a somatostatin analogue. - Patient with Cushing's syndrome - Pregnant woman, likely to be pregnant or breastfeeding - A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice) - A person of full age who is unable to express their consent - Person deprived of their liberty by a judicial or administrative decision - Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether 68Ga-DOTATOC PET / CT is sensitive enough to identify acute inflammatory myocarditis in a population of patients hospitalized for chest pain and for whom a high probability of myocarditis has already been identified using MRI. The prevalence of the disease will be close to 100% at inclusion for these patients;Secondary Objective: 1. Evaluate the frequency of forms that may still be inflammatory (possibly subacute or chronic forms), with PET / CT with 68Ga-DOTATOC performed 3 to 5 months after inclusion, when the classic signs of progressiveness and acute inflammation have generally disappeared (CRP, Troponin-I, myocardial edema on MRI). 2. Analyze the concordance of the results obtained by a blind reading by two senior nuclear doctors.;Primary end point(s): Presence of a significant myocardial uptake which will be (i) visual and (ii) quantitative by measurement of the SUV (Standardized Uptake Values), considered to be significant of 68Ga-DOTATOC during the initial assessment. Calculation of the sensitivity.;Timepoint(s) of evaluation of this end point: upon 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Frequency of significant myocardial uptake of 68Ga-DOTATOC 3 to 5 months after inclusion. 2. Matched results of the two readers;Timepoint(s) of evaluation of this end point: upon 36 months | — |
Countries
France
Contacts
Public ContactHUE ANNE-SOPHIE
CHRU DE NANCY
Outcome results
None listed