National, Multi-center, Prospective, and Retrospective Cohort Study.

NCT04520204 | Unknown

• 1 other identifier: AMI 05.2020
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

National, multi-center, observational, prospective, and retrospective cohort study. The study does not provide for intervention in routine clinical practice. Key goals:

• Obtaining real-world evidence on the diagnosis and treatment of AIM in Russian hospitals, including both long- and short-term findings and outcomes (i.e. during hospitalization, and 6-12 months after the diagnosis establishment).
• Evaluation of the applied approaches to the management of AIM patients for compliance with the clinical recommendations across various hospitals, with a breakdown by equipment status;
• Assessment of patients' treatment adherence after 6 and 12 months. The expected project duration is 3 years. The study subjects will be recruited during the first 24 months unless the investigators decide to terminate or extend the study period. The period of observation for each patient is 6 to 12 months. The project involves retrospective and prospective collection of information from medical records. All patient data shall be recorded by the Investigator into an approved electronic case report form (eCRF). Recruitment period: 2020-2022. Expected number of subjects: 10,000.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Monitoring of the patient

  Recording of all events that occur with the patient for 12 months from the moment of diagnosis Acute myocardial infarction : repeated heart attack, change of therapy, complications from the cardiovascular system, death

  12 monthes

Secondary Outcomes (1)

• Frequency of the following episodes 2. The proportion of patients who continue taking statins, antiplatelets, and drugs from other groups 6 months or 1 year post-discharge.

  12 monthes

Eligibility Criteria

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

Study Population

Adult patients 18+1. Diagnosed acute ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) (ICD 10 I21); the diagnosis is established based on the Fourth Universal Definition of Myocardial Infarction Guidelines 2018 and signed ( or his/her legal representative) informed consent

You may qualify if:

• \. Diagnosed acute ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) (ICD 10 I21); the diagnosis is established based on the Fourth Universal Definition of Myocardial Infarction Guidelines 2018 .
• The diagnosed patient was admitted to the hospital between days 1 and 10 of the current mont.

You may not qualify if:

• \. A patient or his/her legal representative did not sign the IC.

Sponsors & Collaborators

• Healthy Future: lead

Study Sites (1)

Federal State Budgetary Institution NATIONAL MEDICAL CENTER CARDIOLOGY RESEARCH CENTER Ministry of Health of the Russian Federation

Moscow, 121551, Russia

RECRUITING

Study Officials

• Pevzner

  Myasnikov Institute of Clinical Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shakhnovich

CONTACT

+7 9037992718; shakhnovich@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)