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

Sponsor
National Medical Research Center for Therapy and Preventive Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04901091
Collaborator
N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department (Other)
49
1
24
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Not Provided

Study Design

Study Type:
Observational
Actual Enrollment :
49 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
study groupâ„– 1

patients who have left ventricular aneurysm without thrombosis

Other: Not Provided
Not Provided

study groupâ„– 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

Outcome Measures

Primary Outcome Measures

  1. All cause mortality [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.

Secondary Outcome Measures

  1. Cumulative number cardiovascular events [12 months]

    Cardiovascular event is defined on of the following repeated myocardial infarctions, brain strokes, PCI, CABG, pulmonary embolism.

  2. Assessment of adherence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department Moscow Russian Federation

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Medical Research Center for Therapy and Preventive Medicine
ClinicalTrials.gov Identifier:
NCT04901091
Other Study ID Numbers:
  • 01-05-21
First Posted:
May 25, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Medical Research Center for Therapy and Preventive Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022