NCT02717143|Completed
French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI
MYOCARDITIRM
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MYOCARDITIRM
Sponsor study identifier
observational
821
1 country
1
Study Start
April 2016
Actual (reported)Primary Completion
August 25, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2016
Actual (reported)March 23, 2016
Actual (reported)April 2016
Actual (reported)August 25, 2021
Actual (reported)December 31, 2021
Actual (reported)All cause mortality at 1 year of follow-up
1 year
Cardiovascular mortality at 1 year of follow-up
1 year
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
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.
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.
Bichat
Paris, France
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.
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.
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.
Phalla OU, MD. PhD
Assistance Publique - Hôpitaux de Paris
Claire BOULETI
Assistance Publique - Hôpitaux de Paris
821 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2016
First Posted
March 23, 2016
Study Start
April 2016
Actual (reported)Prognostic Role of High Sensitivity Troponin During Follow up in the Evolution of Acute Myocarditis
Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
August 25, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
September 16, 2022
Record last verified: 2022-09
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