Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

Myocarditis Clinical Trial

— AMPHIBIA  

Official title:

Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844151
• Other study ID #: APHP201197
• Status: Recruiting
• Start date: January 23, 2022
• Est. completion date: May 1, 2041

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mathieu Kerneis, MD
• Phone: +33142163001
• Email: mathieu.kerneis[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

Description:

Acute myocarditis is an inflammatory disease of the heart muscle. Its clinical presentation and its etiologies are multiple and make it a complex disease to treat. Its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. The long-term prognosis is poorly understood. Consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. This project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period. The aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis. Features of interest will include : - Clinical - Biological - Etiological - Echocardiographic - Cardiac magnetic resonance imaging - Genetics (for the prospective cohort) - Anatomopathological The collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: May 1, 2041
• Est. primary completion date: May 1, 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Acute myocarditis confirmed by cardiac magnetic resonance according to Lake Louise modified criteria or by endomyocardial biopsy according to histologic, immunologic and immunohistochemic criteria.
• affiliation to the French Health Care System "Sécurité sociale"

Exclusion Criteria:

• Severe valvulopathy
• Complex congenital cardiopathy
• Previous heart transplant
• Known significative coronary disease

Related Conditions & MeSH terms

• Myocarditis

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (23)

Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Cirò A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319. — View Citation

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Caforio AL, Calabrese F, Angelini A, Tona F, Vinci A, Bottaro S, Ramondo A, Carturan E, Iliceto S, Thiene G, Daliento L. A prospective study of biopsy-proven myocarditis: prognostic relevance of clinical and aetiopathogenetic features at diagnosis. Eur Heart J. 2007 Jun;28(11):1326-33. Epub 2007 May 9. — View Citation

Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Heliö T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3. — View Citation

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Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072. Review. — View Citation

Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007. — View Citation

Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7. Review. — View Citation

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Grün S, Schumm J, Greulich S, Wagner A, Schneider S, Bruder O, Kispert EM, Hill S, Ong P, Klingel K, Kandolf R, Sechtem U, Mahrholdt H. Long-term follow-up of biopsy-proven viral myocarditis: predictors of mortality and incomplete recovery. J Am Coll Cardiol. 2012 May 1;59(18):1604-15. doi: 10.1016/j.jacc.2012.01.007. Epub 2012 Feb 22. — View Citation

Harmon KG, Drezner JA, Maleszewski JJ, Lopez-Anderson M, Owens D, Prutkin JM, Asif IM, Klossner D, Ackerman MJ. Pathogeneses of sudden cardiac death in national collegiate athletic association athletes. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):198-204. doi: 10.1161/CIRCEP.113.001376. Epub 2014 Mar 1. — View Citation

Klingel K, Hohenadl C, Canu A, Albrecht M, Seemann M, Mall G, Kandolf R. Ongoing enterovirus-induced myocarditis is associated with persistent heart muscle infection: quantitative analysis of virus replication, tissue damage, and inflammation. Proc Natl Acad Sci U S A. 1992 Jan 1;89(1):314-8. — View Citation

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Leone O, Veinot JP, Angelini A, Baandrup UT, Basso C, Berry G, Bruneval P, Burke M, Butany J, Calabrese F, d'Amati G, Edwards WD, Fallon JT, Fishbein MC, Gallagher PJ, Halushka MK, McManus B, Pucci A, Rodriguez ER, Saffitz JE, Sheppard MN, Steenbergen C, Stone JR, Tan C, Thiene G, van der Wal AC, Winters GL. 2011 consensus statement on endomyocardial biopsy from the Association for European Cardiovascular Pathology and the Society for Cardiovascular Pathology. Cardiovasc Pathol. 2012 Jul-Aug;21(4):245-74. doi: 10.1016/j.carpath.2011.10.001. Epub 2011 Dec 3. — View Citation

Li HS, Ligons DL, Rose NR. Genetic complexity of autoimmune myocarditis. Autoimmun Rev. 2008 Jan;7(3):168-73. doi: 10.1016/j.autrev.2007.11.010. Epub 2007 Dec 3. Review. — View Citation

Lopez-Ayala JM, Pastor-Quirante F, Gonzalez-Carrillo J, Lopez-Cuenca D, Sanchez-Munoz JJ, Oliva-Sandoval MJ, Gimeno JR. Genetics of myocarditis in arrhythmogenic right ventricular dysplasia. Heart Rhythm. 2015 Apr;12(4):766-73. doi: 10.1016/j.hrthm.2015.01.001. Epub 2015 Jan 20. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiac events	Defined as a composite of : All cause death; Resuscitated cardiac arrest; Heart transplant; Longterm mechanical circulatory support; Ventricular arrhythmia after discharge; Hospitalization for heart failure; Hospitalization for myocarditis recurrence	up to 1 years
Secondary	Major cardiac events	Defined as a composite of : All cause death; Resuscitated cardiac arrest; Heart transplant; Longterm mechanical circulatory support; Ventricular arrhythmia after discharge; Hospitalization for heart failure; Hospitalization for myocarditis recurrence	up to 20 years
Secondary	All cause death		up to 20 years
Secondary	Cardiovascular death		up to 20 years
Secondary	Heart transplant	Number of patients with heart transplant	up to 20 years
Secondary	Sustained ventricular arrhythmia after discharge	Number of patients with sustained ventricular arrhythmia after discharge	up to 20 years
Secondary	Resuscitated cardiac arrest	Number of patients with resuscitated cardiac arrest	up to 20 years
Secondary	Longterm mechanical circulatory support	Number of patients implanted with a longterm mechanical circulatory support	up to 20 years
Secondary	Hospitalization for myocarditis recurrence	Number of patients hospitalized for myocarditis recurrence	up to 20 years
Secondary	Hospitalization for heart failure	Number of patients with hospitalization for heart failure	up to 20 years
Secondary	Pericardial drainage	Number of patients with a surgery of pericardial drainage	up to 20 years
Secondary	Supra ventricular arrythmia	Number of patients with a new onset of supra ventricular arrhythmia	up to 20 years
Secondary	High grade atrioventricular block	Number of patients with a new high grade atrioventricular block	up to 20 years
Secondary	Pericarditis	Number of patients with pericarditis diagnosed by the patient referring physician's	up to 20 years
Secondary	Left ventricular systolic function under 50%	Evaluated by transthoracic echocardiography	up to 20 years
Secondary	Therapeutics during hospital stay	Type and duration of therapeutics received during the initial hospital stay	From the day of admission up to 90 days