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Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management

A legfontosabb adatok

Ki végzi
Scientific Institute San Raffaele
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
1000 fő, tervezett
Kezdés
2018. jan. 30.
Várható befejezés
2035. dec. 31.
A vizsgálat típusa
Megfigyeléses, 3 csoport
A vizsgált kezelések
  • support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
A regiszteradat frissítve
2024. szeptember 19.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults whose doctors suspect myocarditis, an inflammation of the heart muscle. People with or without heart rhythm problems can join.

Életkor
18 years or older
Nem
All sexes
A betegség stádiuma
Clinically suspected myocarditis. People join through one of the participating centers.

A részvétel fő kizáró okai

  • People who do not give written informed consent cannot join.
  • People younger than 18 years cannot join.

A regiszter feltételei, szó szerint

Mind a 6 feltétel megnézéseKevesebb

Ki vehet részt

  • Written informed consent
  • Age ≥ 18 years
  • Clinically suspected myocarditis
  • Enrollment performed by one of the participating Centers

Ki nem vehet részt

  • Age < 18 years (paediatric population)
  • Absence of written informed consent

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.

A teljes eredeti leírásKevesebb

1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation. 2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined. 3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis. 4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment. 5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

A vizsgálat 3 csoportja

  • Arrhythmic (A)

    Arrhythmic Group. To oversimplify, specific subgroups of patients will be considered. 1. Group 1: major ventricular arrhythmias (haemodynamically unstable VT, hu-VT; ventricular fibrillation, VF). 2. Group 2: other ventricular arrhythmias (high-burden premature ventricular complexes = hb-PVC; nonsustained VT = NSVT; haemodynamically stable VT = hs-VT). 3. Group 3: bradyarrhythmias (2nd type II or 3rd degree atrioventricular block = advanced AVB; critical sinus pauses = SND). 4. Group 4: supraventricular arrhythmias (atrial fibrillation = AF; atrial flutter = AFlu; atrial tachycardia = AT).

    Kezelés: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

  • Nonarrhythmic (NA)

    Nonarrhythmic Group. To oversimplify, specific subgroups of patients will be considered. 1. Heart failure presentation (and subtypes) 2. Chest pain presentation (and subtypes) 3. Asymptomatic presentation/screening (and subtypes)

    Kezelés: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

  • Subgroups

    For specific study aims, different patient subgroups will be compared. The main groups are hereby reported: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C. Infectious vs. autoimmune vs. toxic myocarditis. D. Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E. Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G. Myocarditis vs. peri-myocarditis/myo-pericarditis. H. Other subgroups.

    Kezelés: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2024. szeptember 19.