Viewing Study NCT04520204



Ignite Creation Date: 2024-05-06 @ 3:06 PM
Last Modification Date: 2024-10-26 @ 1:43 PM
Study NCT ID: NCT04520204
Status: RECRUITING
Last Update Posted: 2022-08-03
First Post: 2020-08-17

Brief Title: National Multi-center Prospective and Retrospective Cohort Study
Sponsor: Healthy Future
Organization: Healthy Future

Study Overview

Official Title: Russian Registry of Acute Myocardial Infarction
Status: RECRUITING
Status Verified Date: 2022-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: REGION
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 ie 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 10000
Detailed Description: 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 periodThe 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

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

EXCLUSION CRITERIA

1 A patient or hisher legal representative did not sign IC

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 patients 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 patients deathdischarge 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 hisher 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None