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

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901091
• Other study ID #: 01-05-21
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Infarction
• Myocardial Infarction
• Thrombosis

Intervention

Other:
• Not Provided
Not Provided

Locations

Country	Name	City	State
Russian Federation	N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department	Moscow

Sponsors (2)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Patients with a fatal outcome will be identified. We will contact the relatives of the deceased patients to clarify the date of death.	12 months
Secondary	Cumulative number cardiovascular events	Cardiovascular event is defined on of the following repeated myocardial infarctions, brain strokes, PCI, CABG, pulmonary embolism.	12 months
Secondary	Assessment of adherence	To 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.	baseline, 3 months, 12 months