Clinical trial NCT06252168: Registry of Acute Myocardial Infarction
Official title: Registry of Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction, Acute
Keywords: Acute Myocardial Infarction
Acute Coronary Syndrome
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2024-02-09
Enrollment: 97500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population icnludes all subjects with verified and suspected acute myocardial infarction (AMI) in the city of Tomsk (Russian Federation) regardless of disease treatment, outcome, and healthcare institution esablishing diagnosis.

Brief summary: The Registry of Acute Myocardial Infarction (RAMI) aims at regular and centralized acquiring and processing standard information about verified and suspected cases of acute myocardial infarction (AMI), monitoring of AMI cases, and establishing AMI diagnosis based on standard diagnostic criteria by doctors involved in the registry. The RAMI obtains data from all medical institutions, which could potentially document any cases of suspected AMI.

Detailed description: The study implements the methodology recommended by the World Health Organization (WHO) using unified diagnostic criteria (clinical, biochemical, electrocardiographic, and autopsy) for acute myocardial infarction (AMI). All primary information is recorded in a special primary registration card, which has been subject to updates in accordance with the requirements. All accumulated data is stored in RAMI analytic database. The database is designed and developed specifically for recording, accumulating, archiving, and statistical processing of collected data. It is equipped with a web user interface, a universal environment for generating consolidated distribution reporting, and the ability to import analytical data into expert analytical systems produced by other manufacturers. Data storage is implemented using the Oracle database management system. The information and analytical system of RAMI has passed the procedure of state registration of the database. Each reported case after the first 28 days from disease onset is assigned a specific diagnostic category (definite myocardial infarction, possible myocardial infarction, unconfirmed myocardial infarction, and insufficient data). At the end of each year of study, RAMI team calculates and analyzes the main epidemiological parameters, characterizing the disease distribution in the studied population (the city of Tomsk, Russian Federation) including morbidity, mortality, and lethality (general, in-hospital, and pre-hospital).

Eligibility criteria: Inclusion Criteria:

* age of at least 20 years;
* being a resident or visitor of the city of Tomsk at a time of AMI onset;
* the presence of definite AMI or possible AMI. Definite AMI is diagnosed in the presence of characteristic ECG changes, regardless of clinical course and changes in serum enzymes; or the presence of typical pain syndrome, "ambiguous" ECG changes, and definite increase in the activity of serum enzymes i.e. exceeding the upper limit of normal by 25% or more; or macroscopically detected focus of myocardial necrosis and (or) fresh thrombotic occlusion of the coronary artery. Possible AMI is registered in the presence of typical pain syndrome with ambiguous ECG changes and an ambiguous (up to 25%) increase in the levels of serum enzymes; or the presence of obstruction in the lumen of at least one coronary artery by at least 50% and (or) the presence of a post-infarction scar in the myocardium with a diameter of 0.5 cm or more, while simultaneously excluding a non-coronary cause of death. In case of atypical clinical picture, ambiguous or absent ECG changes, when the enzyme levels are not determined or their activity does not reach a pathological level, AMI case is considered unconfirmed. In the absence of data that could confirm or not confirm AMI, the case is interpreted as "insufficient data"

Exclusion Criteria:

* none.

Primary outcomes:
measure: Early AMI lethality rate (%)
timeFrame: 28 days
Secondary outcomes:
measure: 12-month AMI lethality rate (%)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center, Russian Academy of Sciences
Study officials:
affiliation: Tomsk NRMC
name: Alexei N. Repin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Tomsk NRMC
name: Sergey A. Okrugin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: