Registry of Acute Myocardial Infarction

Myocardial Infarction, Acute Clinical Trial

— RAMI-Tomsk  

Official title:

Registry of Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252168
• Other study ID #: CRI-211
• Status: Recruiting
• Start date: January 1, 1984
• Est. completion date: December 31, 2050

Study information

• Verified date: February 2024
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: Sergey A. Okrugin, MD, PhD
• Phone: +73822554111
• Email: sao[@]cardio-tomsk.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97500
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2049
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Locations

Country	Name	City	State
Russian Federation	Tomsk National Research Medical Center, Russian Academy of Sciences	Tomsk

Sponsors (2)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences	World Health Organization

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early AMI lethality rate (%)	Early acute myocardial infarction (AMI) lethality rate is calculated as percentage (%) of fatal outcomes that occurred within 28 days since onset of disease among subjects with verified or suspected AMI.	28 days
Secondary	12-month AMI lethality rate (%)	12-month acute myocardial infarction (AMI) lethality rate is calculated as percentage (%) of fatal outcomes that occurred within one year since onset of disease among subjects with verified or suspected AMI.	12 months