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

NCT02717143 | Completed

• 1 other identifier: 15677
• Study Type: observational
• Target: 821
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocarditis; Cardiomyopathy, Dilated; Magnetic Resonance Imaging

Keywords

Acute myocarditis; Dilated cardiomyopathy; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• All cause mortality at 1 year of follow-up

  1 year

• Cardiovascular mortality at 1 year of follow-up

  1 year

Secondary Outcomes (3)

• All cause mortality at 3 years of follow-up

  3 years

• Incidence of cardiovascular events at 3 years of follow-up

  3 years

• Incidence of sequelae of myocarditis in cardiac MRI for patients undergoing cardiac MRI in their monitoring at 3 years of follow-up

  3 years

Study Arms (1)

Acute myocarditis

Patients with a clinical picture suggestive of acute myocarditis: increase of troponin above the threshold defined by the pathological laboratory, associated with at least one of the three following criteria: 1. prolonged chest pain \> 10 minutes, 2. recent infectious context \<7 days 3. young subject and / or absence of cardiovascular risk factors and / or absence of significant coronary lesion Patients will be included after completion of MRI confirm the diagnosis. They will be followed for 3 years, every year, by the doctor who included them in the study. This is an observational study that does not affect the management of patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with clinical features of acute myocarditis previously defined and who underwent cardiac MRI which concluded the diagnosis of acute myocarditis, having agreed to participate in the study and admitted in one of the participating centers.

You may qualify if:

• 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:
• prolonged chest pain\> 10 minutes,
• recent infectious context \<7 days
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

Bichat

Paris, France

Location

Related Publications (16)

• Magnani JW, Dec GW. Myocarditis: current trends in diagnosis and treatment. Circulation. 2006 Feb 14;113(6):876-90. doi: 10.1161/CIRCULATIONAHA.105.584532. No abstract available.

  PMID: 16476862 BACKGROUND

• Andreoletti L, Leveque 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.

  PMID: 19664576 BACKGROUND

• 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.

  PMID: 9312504 BACKGROUND

• 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. doi: 10.1056/NEJM200003093421003.

  PMID: 10706898 BACKGROUND

• 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. doi: 10.7326/0003-4819-141-11-200412070-00005.

  PMID: 15583223 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)00648-x.

  PMID: 12906974 BACKGROUND

• 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.

  PMID: 19389557 BACKGROUND

• Potet J, Rahmouni A, Mayer J, Vignaud A, Lim P, Luciani A, Dubois-Rande 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/radiology.13121811. Epub 2013 May 21.

  PMID: 23696680 BACKGROUND

• 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. doi: 10.1093/eurheartj/ehm076. Epub 2007 May 9.

  PMID: 17493945 BACKGROUND

• Kindermann I, Kindermann M, Kandolf R, Klingel K, Bultmann B, Muller T, Lindinger A, Bohm 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.

  PMID: 18645053 BACKGROUND

• Grun 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.

  PMID: 22365425 BACKGROUND

• Mahfoud F, Ukena C, Kandolf R, Kindermann M, Bohm 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.

  PMID: 22473019 BACKGROUND

• Ukena C, Mahfoud F, Kindermann I, Kandolf R, Kindermann M, Bohm 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.

  PMID: 21239404 BACKGROUND

• 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. doi: 10.1016/j.ahj.2005.03.037.

  PMID: 16442915 BACKGROUND

• 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. doi: 10.1016/0002-8703(94)90483-9.

  PMID: 8037097 BACKGROUND

• Bouleti C, Bejan-Angoulvant T, Servoz C, Carsten E, Genet T, Ternacle J, Deux JF, Puymirat E, Mousseaux E, Alos B, Garcia R, Bonnet G, Jacquier A, Lattuca B, Huttin O, Akodad M, Redheuil A, Angoulvant D, Ou P; MyocarditIRM Investigators. Contemporary Epidemiology, Management, and In-Hospital Outcomes of Acute Myocarditis: The Prospective Multicenter MyocarditIRM Study. JACC Heart Fail. 2025 Aug;13(8):102492. doi: 10.1016/j.jchf.2025.03.038. Epub 2025 Jun 13.

  PMID: 40516214 DERIVED

MeSH Terms

Conditions

Myocarditis; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Phalla OU, MD. PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Claire BOULETI

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 23, 2016
• Study Start: April 1, 2016
• Primary Completion: August 25, 2021
• Study Completion: December 31, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)