An observational study in Acute Myocardial Infarction, sponsored by Healthy Future. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Healthy Future · Observational
National, multi-center, observational, prospective, and retrospective cohort study. The study does not provide for intervention in routine clinical practice.
Key goals:
and 6-12 months after the diagnosis establishment).
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.
The Russian Registry of Acute Myocardial Infarction study is an independent study initiated by the investigators;
The partner inpatient hospitals will provide data on every patient with known acute myocardial infarction (I21) admitted between days 1 and 10 of each month during the recruitment period.The Russian Registry of Acute Myocardial Infarction study is an independent study initiated by the investigators;
For every engaged hospital (medical center) the investigators will designate a 2-3 person task team, including a Team Leader;
The participants shall be kept informed and coordinated via email and messengers. The website of the Russian Society of Emergency Cardiology.
The study will be hosted by the CRM Quinta® platform.
Administration, data entry monitoring, and statistical processing will be carried out by Aston Consulting (a certified personal data operator.)
AO Aston Consulting has a license for storage and processing of personal data in accordance with the applicable legislation.
PATIENTS.
INCLUSION CRITERIA
EXCLUSION CRITERIA
STUDY ASSESSMENTS
The following information will be collected and entered into CRF: Full name
Residential address
Phone number of patients or their legal representatives' Demographic profile. Weight, height
Social status (education, job title, occupation status)
Co-morbidities
Clinical signs and symptoms
Drug therapy.
Clinical outcomes during the hospital stay.
Drug therapy and clinical outcomes in 6 and 12 months after the diagnosis establishment.
Hospitals wishing to join the study must contact any of the project coordinators and complete the Participation questionnaire (Appendix 4).
The Registry enrolment process starts in 2020 and will continue for 24 months. The hospitals that will not be able to start the enrolment in 2020 will have the chance to do it before December 31, 2022, and perform the follow-up monitoring for the next 12 months.
At the moment of the enrolment, the patient's data are to be entered into the online database. Any new data that might appear during the hospital stay will be successively or immediately entered into the database at the moment of the patient's death/discharge. The data received during an in-person or a phone contact 6 or 12 months after the enrolment will also be entered into the database.
Shall the initiators have any questions regarding the entered data, they will ask the participants to elaborate, clarify, or correct the data.
If the patient dies before the enrolment to the study, his/her data shall be entered into the database retrospectively.
The patients (or their legal representatives) enrolled to the Registry must be kept informed about the inclusion in this observational program and give their written consent for participation (patients who died or are otherwise unable to sign the consent to the processing of personal data will be enrolled on a de-identified basis.)
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Healthy Future is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
The diagnosed patient was admitted to the hospital between days 1 and 10 of the current mont.
Exclusion Criteria:
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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
Time frame: 12 monthes
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.
Record the f- recurrent MI * heart failure * ischemic stroke * clinically significant bleeding * unplanned revascularisation post-discharge frequency of complications:
Time frame: 12 monthes
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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