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

NCT04901091 | Completed

• 1 other identifier: 01-05-21
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

left ventricular aneurysm, transmural myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative number cardiovascular events

  12 months

• Assessment of adherence

  baseline, 3 months, 12 months

Study Arms (3)

study group№ 1

patients who have left ventricular aneurysm without thrombosis

Other: Not Provided

study group№ 2

patients who have left ventricular aneurysm with thrombosis

Other: Not Provided

control group

patients who have not left ventricular aneurysm

Other: Not Provided

Interventions

Not Provided OTHER

Not Provided

control group; study group№ 1; study group№ 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology

You may qualify if:

• 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
• Patients from 18 to 85 years of age
• Patients who live in Moscow and Moscow region
• Patients who signed the consent to participate in the study and processing of personal data.

You may not qualify if:

• Patients who refused to come for a second appointment or answer the questionnaire questions
• Patients who had repeated myocardial infarction

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead
• N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department: collaborator

Study Sites (1)

N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department

Moscow, Russia

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 25, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

RU (1)