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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04901091
Acronym
SIBYL
Enrollment
49
Registered
2021-05-25
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

left ventricular aneurysm, transmural myocardial infarction

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.

Interventions

Not Provided

Sponsors

N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department
CollaboratorUNKNOWN
National Medical Research Center for Therapy and Preventive Medicine
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
All cause mortality12 monthsPatients with a fatal outcome will be identified. We will contact the relatives of the deceased patients to clarify the date of death.

Secondary

MeasureTime frameDescription
Cumulative number cardiovascular events12 monthsCardiovascular event is defined on of the following repeated myocardial infarctions, brain strokes, PCI, CABG, pulmonary embolism.
Assessment of adherencebaseline, 3 months, 12 monthsTo assess adherence to the recommended therapy at enrollment and during the first and second visits, the original questionnaire The Scale of Adherence of the National Society for Evidence-based Pharmacotherapy will be used. The commitment scale has two modifications to assess potential and initial actual commitment. The questionnaire can be used both to assess overall adherence to drug therapy and to diagnose adherence to a specific drug. The maximum number of points on the scale is 4 points. The minimum number of points on the scale is 0 points. 4 points means complete non-adherence. 0 points means full commitment.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026