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MyocarditisMYOCARDITIRMNCT02717143

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

An observational study of Myocarditis and Cardiomyopathy, Dilated, run by French Cardiology Society at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
821 participants
Where
1 siteFrance
Study dates
Apr 2016to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Bichat

    Paris

Other trials in France

About this study

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.

Read the detailed 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.

Keywords
Acute myocarditis, Dilated cardiomyopathy, Magnetic resonance imaging
Medical subject headings
Myocarditis, Cardiomyopathy, Dilated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02717143
Study groupRoleWhat they receive
Acute myocarditisPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality at 1 year of follow-up

    Measured: 1 year

  2. Cardiovascular mortality at 1 year of follow-up

    Measured: 1 year

Secondary outcomes (3)

  1. All cause mortality at 3 years of follow-up

    Measured: 3 years

  2. 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

    Measured: 3 years

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion25 Aug 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
821 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02717143
Sponsor's protocol ID
15677
Acronym
MYOCARDITIRM
Status last verified
Sep 2022
First submitted
18 Mar 2016
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16476862

  • 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.

    PubMed 19664576

  • 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.

    PubMed 9312504

  • 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.

    PubMed 10706898

  • 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.

    PubMed 15583223

  • 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.

    PubMed 12906974

  • 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.

    PubMed 19389557

  • 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.

    PubMed 23696680

  • 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.

    PubMed 17493945

  • 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.

    PubMed 18645053

  • 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.

    PubMed 22365425

  • 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.

    PubMed 22473019

  • 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.

    PubMed 21239404

  • 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.

    PubMed 16442915

  • 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.

    PubMed 8037097

Questions about this trial

What is this clinical trial studying?

An observational study of Myocarditis and Cardiomyopathy, Dilated, run by French Cardiology Society at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality at 1 year of follow-up (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02717143, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

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