MyocarditisNCT06447935
Acute Eosinophilic Myocarditis International Registry
An observational study of Myocarditis, run by Niguarda Hospital at 1 site in Italy.
Trial summary
Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocarditis
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2021to 27 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A retrospective observational cohort of eosinophilic myocarditis patients
Patients with histological diagnosis gained during an hospitalization within 30 days from symptoms onset.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.
Read the detailed description
Eosinophilic myocarditis (EM) is an acute life-threatening inflammatory disease of the heart. We collect clinical, histologic, laboratory, diagnostic and imaging data regarding acute EM with a histological diagnosis and symptoms onset within 30 days from first medical contact from hospitals around the world. The main objective is to investigate and describe clinical presentation, main systemic conditions associated and outcomes of the first series of patients with acute myocarditis and histological evidence of eosinophilic infiltration within myocardium.
- Conditions
- Myocarditis
- Being tested
- No intervention
- Keywords
- Eosinophilic Myocarditis, Endomyocardial Biopsy
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
not applicable - no intervention required
| Study group | Role | What they receive |
|---|---|---|
| Acute Eosinophilic Myocarditis | Patients affected by Acute Eosinophilic Myocarditis with the following inclusion criteria:
1. histologically EM proven "borderline" (presence of inflammatory infiltrate) or "active" (presence of inflammatory infiltrate plus myocardial necrosis) myocarditis, according to the Dallas criteria;
2. acute presentation defined by the onset of cardiac symptoms within 30 days before admission. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural History of Eosinophilic Myocarditis
Proportion of patients who die or need a heart transplantation from index admission.
Measured: 3 year
Secondary outcomes (1)
Natural History of Eosinophilic Myocarditis subgroups based on etiology
Proportion of patients who die or need a heart transplantation from index admission dividing patients based on the underlying condition (for instance idiopathic, hypersensitivity, eosinophilic granulomatosis with polyangiitis,…)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start16 Nov 2021
- Primary completion2 Jun 2022
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447935
- Sponsor's protocol ID
- NIGUARDA H
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ammirati E, Palazzini M, Lehtonen J, Potena L, Mayranpaa MI, Ragback J, Foa A, Uribarri A, Thiele H, Vidal-Burdeus M, Freund A, Gustafsson F, Tschope C, Elsanhoury A, Ihle J, Rudi WS, Grabmaier U, Merlo M, Melenovsky V, Weislova I, Jellinghaus S, Linke A, Baldovini C, Adorisio R, Kuchynka P, Palecek T, Krejci J, Poloczkova H, Caterino AL, Gilotra NA, Lovell JP, Macomb EP, Shih J, Hong K, Rossi VA, Ruschitzka F, Cavallini C, Riccini C, Kamal M, Huang F, Groh M, Gentile P, Garascia A, Lala A, Shimokawa H, Vandenbriele C, Sionis A, Schmidt M, Grosu A, Bollano E, Turco A, Crespo-Leiro MG, Couto-Mallon D, Cannata A, Bromage DI, Narducci ML, Cicchitti V, Ianni U, De Luca L, Mistrulli R, Frea S, Raineri C, Schroeder JW, Arias AM, Emdin M, Corda M, Pasqualucci D, Greulich S, Gawaz M, Manuylova T, Martinez-Selles M, Hernandez Perez FJ, Martin Centellas A, Dominguez F, Gaillet A, D'Alessandris N, Trankle C, Halushka MK, Moroni F, Abbate A, Basso C, Sinagra G, Veronese G, Camici PG, Adler ED, Bernasconi DP, Klingel K, Cooper LT Jr. Natural History of Patients With Histologically Proven Acute Eosinophilic Myocarditis. Circulation. 2026 Mar 3;153(9):634-652. doi: 10.1161/CIRCULATIONAHA.125.074797. Epub 2026 Feb 6.
PubMed 41645905
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Eosinophilic Myocarditis International Registry
- ClinicalTrials.gov ID
- NCT06447935
- Acronym / sponsor ID
- NIGUARDA H
- Conditions
- Myocarditis
- Keywords
- Eosinophilic Myocarditis, Endomyocardial Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.
Detailed description
Eosinophilic myocarditis (EM) is an acute life-threatening inflammatory disease of the heart. We collect clinical, histologic, laboratory, diagnostic and imaging data regarding acute EM with a histological diagnosis and symptoms onset within 30 days from first medical contact from hospitals around the world. The main objective is to investigate and describe clinical presentation, main systemic conditions associated and outcomes of the first series of patients with acute myocarditis and histological evidence of eosinophilic infiltration within myocardium.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Eosinophilic Myocarditis | – | Other: No interventionPatients affected by Acute Eosinophilic Myocarditis with the following inclusion criteria: 1. histologically EM proven "borderline" (presence of inflammatory infiltrate) or "active" (presence of inflammatory infiltrate plus myocardial necrosis) myocarditis, according to the Dallas criteria; 2. acute presentation defined by the onset of cardiac symptoms within 30 days before admission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A retrospective observational cohort of eosinophilic myocarditis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionnot applicable - no intervention required | Other | Acute Eosinophilic Myocarditis |
Primary outcome
Natural History of Eosinophilic Myocarditis
Time frame: 3 year
Proportion of patients who die or need a heart transplantation from index admission.
1 secondary outcome
Natural History of Eosinophilic Myocarditis subgroups based on etiology
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 41645905Ammirati E, Palazzini M, Lehtonen J, Potena L, Mayranpaa MI, Ragback J, Foa A, Uribarri A, Thiele H, Vidal-Burdeus M, Freund A, Gustafsson F, Tschope C, Elsanhoury A, Ihle J, Rudi WS, Grabmaier U, Merlo M, Melenovsky V, Weislova I, Jellinghaus S, Linke A, Baldovini C, Adorisio R, Kuchynka P, Palecek T, Krejci J, Poloczkova H, Caterino AL, Gilotra NA, Lovell JP, Macomb EP, Shih J, Hong K, Rossi VA, Ruschitzka F, Cavallini C, Riccini C, Kamal M, Huang F, Groh M, Gentile P, Garascia A, Lala A, Shimokawa H, Vandenbriele C, Sionis A, Schmidt M, Grosu A, Bollano E, Turco A, Crespo-Leiro MG, Couto-Mallon D, Cannata A, Bromage DI, Narducci ML, Cicchitti V, Ianni U, De Luca L, Mistrulli R, Frea S, Raineri C, Schroeder JW, Arias AM, Emdin M, Corda M, Pasqualucci D, Greulich S, Gawaz M, Manuylova T, Martinez-Selles M, Hernandez Perez FJ, Martin Centellas A, Dominguez F, Gaillet A, D'Alessandris N, Trankle C, Halushka MK, Moroni F, Abbate A, Basso C, Sinagra G, Veronese G, Camici PG, Adler ED, Bernasconi DP, Klingel K, Cooper LT Jr. Natural History of Patients With Histologically Proven Acute Eosinophilic Myocarditis. Circulation. 2026 Mar 3;153(9):634-652. doi: 10.1161/CIRCULATIONAHA.125.074797. Epub 2026 Feb 6.
- Individual participant dataSharing planned: Undecided
Related trials for Myocarditis
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
Not yet recruitingObservational study
Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study
Immune Checkpoint Inhibitor-Related Myocarditis
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingObservational study
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Myocarditis, Myocarditis Acute
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. 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 Italy. 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?
Natural History of Eosinophilic Myocarditis (time frame: 3 year). 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 NCT06447935, which also lists 1 linked publication.
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 7 Jun 2024.