Status:
RECRUITING
Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
Myocarditis Acute
Inflammatory Cardiomyopathy
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biom...
Detailed Description
The primary endpoint of the study will be the characterization of a broad national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. The secondary endpoints of the study wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- • Presence of at least one compatible symptom and at least one objective finding in diagnostic tests (Figure 2), according to the consensus document of the European Society of Cardiology (1):
- A. Clinical presentation:
- Acute chest pain: pericardial or pseudo-ischemic.
- Dyspnea on exertion or at rest for up to 3 months.
- Dyspnea on exertion or at rest for 3 months - 1 year.
- Unexplained palpitations / arrhythmias, sudden death recovered.
- Unexplained cardiogenic shock.
- B. Findings in complementary tests:
- ECG: new onset AV block, new onset bundle branch block, ST segment elevation/depression, T wave inversion
- Elevation of TnI/TnT
- Segmental or global contractility alterations not explained by other causes
- Positive Lake Louise criteria in cardiac MRI (13) (Annex III Figure S1) • Patients who have given their informed consent.
Exclusion
Key Trial Info
Start Date :
April 9 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06898762
Start Date
April 9 2023
End Date
December 31 2028
Last Update
March 27 2025
Active Locations (1)
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1
HCUVA
Murcia, Murcia, Spain, 30120