NCT05949450

Brief Summary

The goal of this observational study is to observe if ultra-sensitive troponins (us) measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac magnetic resonance imaging (MRI), in patients suffering from myocarditis. The investigators will collect patient events by telephone, once a year for 4 years.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2023Jul 2030

First Submitted

Initial submission to the registry

June 8, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

July 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6.5 years

First QC Date

June 8, 2023

Last Update Submit

July 13, 2023

Conditions

Myocarditis

Keywords

myocarditistroponine us

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events (MACE) rate at 4 years

    MACE being defined by a composite criterion: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) cardiac transplantation,4) documented sustained ventricular arrhythmias \>30s, 5) recurrence of myocarditis.

    4 years

Secondary Outcomes (10)

  • Troponin us measured at 3 to 6 months

    3 to 6 months

  • MACE apparition rate

    3 to 6 months

  • Troponin us measured at 3 to 6 months

    3 to 6 months

  • watts generated on stress test at 3 to 6 months

    3 to 6 months

  • Troponin Us measured at 3 to 6 months

    3 to 6 months

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any patient hospitalized for myocarditis at Grenoble Alpes University Hospital (CHUGA) or at Lyon University Hospital, with standardized reassessment at 3-6 months.

You may qualify if:

  • Male or female patients over 18 years of age
  • Patients hospitalized at Grenoble Alpes University Hospital and Lyon University Hospital between June 2016 and June 2025
  • Having presented chest pain and ≥1 diagnostic criteria or if no chest pain, presence of ≥2 diagnostic criteria below :
  • Electrical abnormalities (supra- or sub-ST, T-wave inversion, atrioventricular blocks 1-3 conduction disorders)
  • Elevation of cardiac biomarkers (troponin)
  • Kinetic abnormalities on cardiac ultrasound
  • Associated with ≥2 MRI criteria of tissue abnormality (edema, hyperhemia, myocardial fibrosis)
  • Patient affiliated to a social security scheme or beneficiary of such a scheme
  • No opposition to participation

You may not qualify if:

  • Absence of documented coronary artery disease (cardiac CT or coronary angiography) or age \<30 and low risk of coronary artery disease.
  • Myocarditis secondary to immunotherapy.
  • Presence of documented coronary artery disease (coronary angiography or cardiac CT)
  • Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
  • Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
  • Severe valve disease
  • Takotsubo
  • Constrictive or chronic pericarditis
  • Loeffler's endocarditis
  • Non-compaction of the left ventricle
  • Cardiac tumor
  • Pulmonary embolism
  • Coronary spasm
  • Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code (pregnant women, parturients, nursing mothers; persons deprived of liberty by judicial or administrative decision; protected adults)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

La Tronche, 38700, France

Location

Related Publications (7)

  • Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12.

    PMID: 33176455BACKGROUND

  • Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio 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.

    PMID: 23824828BACKGROUND

  • Barone-Rochette G, Augier C, Rodiere M, Quesada JL, Foote A, Bouvaist H, Marliere S, Fagret D, Baguet JP, Vanzetto G. Potentially simple score of late gadolinium enhancement cardiac MR in acute myocarditis outcome. J Magn Reson Imaging. 2014 Dec;40(6):1347-54. doi: 10.1002/jmri.24504. Epub 2013 Dec 1.

    PMID: 24293405BACKGROUND

  • Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045.

    PMID: 26764061BACKGROUND

  • Aquaro GD, Perfetti M, Camastra G, Monti L, Dellegrottaglie S, Moro C, Pepe A, Todiere G, Lanzillo C, Scatteia A, Di Roma M, Pontone G, Perazzolo Marra M, Barison A, Di Bella G; Cardiac Magnetic Resonance Working Group of the Italian Society of Cardiology. Cardiac MR With Late Gadolinium Enhancement in Acute Myocarditis With Preserved Systolic Function: ITAMY Study. J Am Coll Cardiol. 2017 Oct 17;70(16):1977-1987. doi: 10.1016/j.jacc.2017.08.044.

    PMID: 29025554BACKGROUND

  • Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.

    PMID: 29025553BACKGROUND

  • Wong BTW, Christiansen JP. Clinical Characteristics and Prognostic Factors of Myocarditis in New Zealand Patients. Heart Lung Circ. 2020 Aug;29(8):1139-1145. doi: 10.1016/j.hlc.2020.01.007. Epub 2020 Feb 17.

    PMID: 32094080BACKGROUND

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Gilles Barone-Rochette, MD, PhD

CONTACT

0476768888gbarone@chu-grenoble.fr

Clémence Charlon, MSc

CONTACT

0476766652ccharlon@chu-grenoble.fr

Study Design

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

Study Record Dates

First Submitted

June 8, 2023

First Posted

July 18, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

July 18, 2023

Record last verified: 2023-06

Locations

FR(1)