French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI

Magnetic Resonance Imaging Clinical Trial

— MYOCARDITIRM  

Official title:

French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717143
• Other study ID #: 15677
• Status: Completed
• Start date: April 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute myocarditis is a serious illness affecting a young population with a very variable course (of full recovery at the onset of dilated cardiomyopathy (DCM), or even sudden death). Very few studies have examined the predictors of death and serious cardiovascular events in acute myocarditis and have carried on numbers of restricted patients. What little data results in a lack of a precise recommendation on the management and the follow-up period of patients.

This observational study should identify serious prognostic factor for cardiovascular events in order to provide a support strategy and more appropriate monitoring of myocarditis.

Description:

Patients included in the study benefit from clinical monitoring, ultrasound and MRI as planned according to the habits of the center, regardless of the study. These clinical monitoring data, ultrasound and MRI will be collected as part of the study and if necessary telephone follow-up of cardiologists contractors will be made to complete the data. No additional examination will be conducted as part of this study. The data collected especially for cardiac MRI, will be based on the current monitoring protocol in each center.

All patients included in this study have received information and signed a consent to the use of their data during hospitalization and follow-up.

As part of this study, the inclusions are planned for a period of 2 years or more to reach a recruitment of 700 patients. The tracking target is 3 years, with an annual follow-up.

Patient follow-up is made by the doctor who selected the patient. Clinical follow-up will be made at a consultation normally provided for in hospital or cardiology practice in this type of pathology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: December 31, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged 18 years and over

• Hospitalized suspect table of acute myocarditis: Eligible patients must have an increase of troponin I greater than the threshold value of the pathological laboratory of Biochemistry, associated with at least one of the three following criteria:

1. prolonged chest pain> 10 minutes,

2. recent infectious context <7 days

3. subject young and / or absence of cardiovascular risk factors and / or absence of significant coronary lesions in coronary angiography if the patient had a coronary angiography.

• Having received a cardiac MRI which concluded the diagnosis of acute myocarditis according to the usual criteria of the center (Lake Louise criteria changed according to the habits of the center) There myocarditis when at least two of the following criteria are met: hyperintense T2; hyperintense Diffusion; myocardium ratio signal / peripheral muscle Gadolinium> 4; contrast enhancement after injection of gadolinium chelate in cine-steady-state free precession (SSFP); nonischemic type of signal on delayed enhancement. These anomalies are segmental topography typically subepicardial. The analysis is made of the 17 segments of the left ventricle.

• Patient was informed and has given its consent for the study

Exclusion Criteria:

• Refusal of consent

• Claustrophobia

• Formal contraindications to MRI (allergic reaction to gadolinium chelates, porters pregnancy or patients against-indicated materials listed on the site MRI Safety "www.MRIsafety.com") :

• Incompatible heart Pacemaker and Defibrillator

• heart valve prostheses: valves Starr

• Metal splinters

• Coils intra cranial, intra cerebral surgical clips, bypass valves

• Neurological stimulators

• Insulin Pumps

• Orthopedic Materials: cervical fixation with cervical Halo vest or fixer

• Body piercing not be withdrawn

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Magnetic Resonance Imaging
• Myocarditis

Locations

Country	Name	City	State
France	Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (15)

Andréoletti L, Lévêque N, Boulagnon C, Brasselet C, Fornes P. Viral causes of human myocarditis. Arch Cardiovasc Dis. 2009 Jun-Jul;102(6-7):559-68. doi: 10.1016/j.acvd.2009.04.010. Epub 2009 Jul 31. Review. — View Citation

Bowles NE, Ni J, Kearney DL, Pauschinger M, Schultheiss HP, McCarthy R, Hare J, Bricker JT, Bowles KR, Towbin JA. Detection of viruses in myocardial tissues by polymerase chain reaction. evidence of adenovirus as a common cause of myocarditis in children and adults. J Am Coll Cardiol. 2003 Aug 6;42(3):466-72. — View Citation

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

Eckart RE, Scoville SL, Campbell CL, Shry EA, Stajduhar KC, Potter RN, Pearse LA, Virmani R. Sudden death in young adults: a 25-year review of autopsies in military recruits. Ann Intern Med. 2004 Dec 7;141(11):829-34. — 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

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

Kindermann I, Kindermann M, Kandolf R, Klingel K, Bültmann B, Müller T, Lindinger A, Böhm M. Predictors of outcome in patients with suspected myocarditis. Circulation. 2008 Aug 5;118(6):639-48. doi: 10.1161/CIRCULATIONAHA.108.769489. Epub 2008 Jul 21. Erratum in: Circulation.2008 Sep 16;118(12): e493. — View Citation

Magnani JW, Danik HJ, Dec GW Jr, DiSalvo TG. Survival in biopsy-proven myocarditis: a long-term retrospective analysis of the histopathologic, clinical, and hemodynamic predictors. Am Heart J. 2006 Feb;151(2):463-70. — View Citation

Magnani JW, Dec GW. Myocarditis: current trends in diagnosis and treatment. Circulation. 2006 Feb 14;113(6):876-90. Review. — View Citation

Mahfoud F, Ukena C, Kandolf R, Kindermann M, Böhm M, Kindermann I. Blood pressure and heart rate predict outcome in patients acutely admitted with suspected myocarditis without previous heart failure. J Hypertens. 2012 Jun;30(6):1217-24. doi: 10.1097/HJH.0b013e328352b9ca. — View Citation

McCarthy RE 3rd, Boehmer JP, Hruban RH, Hutchins GM, Kasper EK, Hare JM, Baughman KL. Long-term outcome of fulminant myocarditis as compared with acute (nonfulminant) myocarditis. N Engl J Med. 2000 Mar 9;342(10):690-5. — View Citation

Mendes LA, Dec GW, Picard MH, Palacios IF, Newell J, Davidoff R. Right ventricular dysfunction: an independent predictor of adverse outcome in patients with myocarditis. Am Heart J. 1994 Aug;128(2):301-7. — View Citation

Potet J, Rahmouni A, Mayer J, Vignaud A, Lim P, Luciani A, Dubois-Randé JL, Kobeiter H, Deux JF. Detection of myocardial edema with low-b-value diffusion-weighted echo-planar imaging sequence in patients with acute myocarditis. Radiology. 2013 Nov;269(2):362-9. doi: 10.1148/radiol.13121811. Epub 2013 May 21. — View Citation

Sinagra G, Maras P, D'Ambrosio A, Gregori D, Bussani R, Silvestri F, Morgera T, Pinamonti B, Salvi A, Alberti E, Di Lenarda A, Lardieri G, Klugmann S, Camerini F. [Clinical polymorphic presentation and natural history of active myocarditis: experience in 60 cases]. G Ital Cardiol. 1997 Aug;27(8):758-74. Italian. — View Citation

Ukena C, Mahfoud F, Kindermann I, Kandolf R, Kindermann M, Böhm M. Prognostic electrocardiographic parameters in patients with suspected myocarditis. Eur J Heart Fail. 2011 Apr;13(4):398-405. doi: 10.1093/eurjhf/hfq229. Epub 2011 Jan 14. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality at 1 year of follow-up		1 year
Primary	Cardiovascular mortality at 1 year of follow-up		1 year
Secondary	All cause mortality at 3 years of follow-up		3 years
Secondary	Incidence of cardiovascular events at 3 years of follow-up	Incidence of heart failure requiring hospitalization, diagnostic of DCM not posed before the episode of myocarditis, stroke, heart transplant	3 years
Secondary	Incidence of sequelae of myocarditis in cardiac MRI for patients undergoing cardiac MRI in their monitoring at 3 years of follow-up		3 years