Clinical trial NCT04901091: Study of the Immediate and Long-term Outcomes of the Disease in Patients With Left Ventricular Aneurysm Complicated and Uncomplicated by Thrombosis After Transmural Myocardial Infarction, According to the Hospital Registry: SIBYL
Official title: Study of the Immediate and Long-term Outcomes of the Disease in Patients With Left Ventricular Aneurysm Complicated and Uncomplicated by Thrombosis After Transmural Myocardial Infarction, According to the Hospital Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: left ventricular aneurysm, transmural myocardial infarction
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department
First posted: 2021-05-25
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology

Brief summary: A prospective non-interventional study aimed to evaluate the immediate and long-term outcomes in patients with left ventricular aneurysm after transmural myocardial infarction.

A registry of patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology will be created. The registry will include all consecutive hospitalized patients from from January 1, 2021 to December 31, 2021 who meet the inclusion criteria Based on this registry, patients will be divided into groups : patients with left ventricular aneurysm and patients without aneurysm, patients with left ventricular thrombosis and patients without thrombosis.

Patients will be contacted in 3 and 12 months. Surviving patients will be invited to appointment for an ECG, echocardiography and survey. The cardiovascular events during this period will be recorded.

The factors determining the prognosis of patients and their concomitant diseases, immediate and long-term prognoses, therapeutic measures and drug therapy at the hospital and outpatient stages, and patients ' adherence to therapy will be analyzed.


Eligibility criteria: Inclusion Criteria:

1. Men and women who had acute transmural myocardial infarction and who were hospitalized to the Emergency Cardiology Department of the N. V. Sklifosovsky Research Institute of Emergency Medicine from January 1, 2021 to December 31, 2021
2. Patients from 18 to 85 years of age
3. Patients who live in Moscow and Moscow region
4. Patients who signed the consent to participate in the study and processing of personal data.

Exclusion Criteria:

1. Patients who refused to come for a second appointment or answer the questionnaire questions
2. Patients who had repeated myocardial infarction
3. Non-compliance with inclusion criteria

Primary outcomes:
measure: All cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: Cumulative number cardiovascular events
timeFrame: 12 months
measure: Assessment of adherence
timeFrame: baseline, 3 months, 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department
Study officials:
References: