Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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 biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new hsa-RNA-Chr8:96 biomarker for the diagnosis of myocarditis compared to conventional diagnosis; 3) to identify acquired and inherited mutations, and their interaction with the environment, which explain the susceptibility to myocarditis, its severity and response to treatment; 4) to study the lower incidence in women and the influence of age, considering socio-health and genetic factors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ • 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.

Locations
Other Locations
Spain
HCUVA
RECRUITING
Murcia
Contact Information
Primary
Domingo Pascual Figal, MD
coordinacion@premyo.org
868885273
Time Frame
Start Date: 2023-04-09
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 3000
Related Therapeutic Areas
Sponsors
Leads: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

This content was sourced from clinicaltrials.gov