Myocardial InfarctionSIBYLNCT04901091
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
An observational study of Myocardial Infarction, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Not Provided
- How many people
- 49 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology
Who may be able to join
- 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.
Who cannot join
- Patients who refused to come for a second appointment or answer the questionnaire questions
- Patients who had repeated myocardial infarction
- Non-compliance with inclusion criteria
Trial locations and contacts
1 site in 1 country.
Russia1 site
N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department
Moscow
About this study
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
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.
Read more
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
- Being tested
- Not Provided
- Keywords
- left ventricular aneurysm, transmural myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not ProvidedOther
Not Provided
| Study group | Role | What they receive |
|---|---|---|
| study group№ 1 | patients who have left ventricular aneurysm without thrombosis Receives: Other: Not Provided | |
| study group№ 2 | patients who have left ventricular aneurysm with thrombosis Receives: Other: Not Provided | |
| control group | patients who have not left ventricular aneurysm Receives: Other: Not Provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Cumulative number cardiovascular events
Cardiovascular event is defined on of the following repeated myocardial infarctions, brain strokes, PCI, CABG, pulmonary embolism.
Measured: 12 months
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.
Measured: baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901091
- Sponsor's protocol ID
- 01-05-21
- Acronym
- SIBYL
- Status last verified
- Apr 2023
- First submitted
- 14 May 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04901091
- Acronym / sponsor ID
- SIBYL / 01-05-21
- Conditions
- Myocardial Infarction
- Keywords
- left ventricular aneurysm, transmural myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Collaborators
- N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Healthcare Department
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| study group№ 1 | – | Other: Not Providedpatients who have left ventricular aneurysm without thrombosis |
| study group№ 2 | – | Other: Not Providedpatients who have left ventricular aneurysm with thrombosis |
| control group | – | Other: Not Providedpatients who have not left ventricular aneurysm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with transmural myocardial infarction admitted to the Emergency Department of Cardiology
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who refused to come for a second appointment or answer the questionnaire questions
- Patients who had repeated myocardial infarction
- Non-compliance with inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not ProvidedNot Provided | Other | control group, study group№ 1, study group№ 2 |
Primary outcome
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.
2 secondary outcomes
Cumulative number cardiovascular events
Time frame: 12 months
Assessment of adherence
Time frame: baseline, 3 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.