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 (SIBYL)

April 27, 2023 updated by: National Medical Research Center for Therapy and Preventive Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group№ 1
patients who have left ventricular aneurysm without thrombosis
Other: Not Provided
Not Provided
study group№ 2
patients who have left ventricular aneurysm with thrombosis
Other: Not Provided
Not Provided
control group
patients who have not left ventricular aneurysm
Other: Not Provided
Not Provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative number cardiovascular events
Time Frame: 12 months
Cardiovascular event is defined on of the following repeated myocardial infarctions, brain strokes, PCI, CABG, pulmonary embolism.
12 months
Assessment of adherence
Time Frame: baseline, 3 months, 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-05-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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