Myocardial Infarction, AcuteRAMI-TomskNCT06252168
Registry of Acute Myocardial Infarction
An observational study of Myocardial Infarction, Acute, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myocardial Infarction, Acute
- How many people
- 97,500 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 1984to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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"
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk
Nina D. Anfinogenova, PhD, +73822554111, anfiyj@gmail.com
About this study
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.
Read the 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).
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Acute Myocardial Infarction, Acute Coronary Syndrome
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Jan 1984
- Primary completion31 Dec 2049 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 97,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
- Investigators
- Alexei N. Repin, MD, PhD, Study director, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252168
- Sponsor's protocol ID
- CRI-211
- Acronym
- RAMI-Tomsk
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06252168
- Acronym / sponsor ID
- RAMI-Tomsk / CRI-211
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Acute Myocardial Infarction, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 97,500 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 1 Jan 1984 (actual)
- Primary completion
- 31 Dec 2049 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 9 Feb 2024 (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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early AMI lethality rate (%)
Time frame: 28 days
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.
1 secondary outcome
12-month AMI lethality rate (%)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Alexei N. Repin, MD, PhD study director
Tomsk NRMC
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, Acute, run by Tomsk National Research Medical Center of the Russian Academy of Sciences 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina D. Anfinogenova, PhD (+73822554111, cardio.intl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early AMI lethality rate (%) (time frame: 28 days). 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 24 Jun 2026.