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National, Multi-center, Prospective, and Retrospective Cohort Study. (REGION)

2. august 2022 oppdatert av: Healthy Future

Russian Registry of Acute Myocardial Infarction

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 (i.e. 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: 10,000.

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

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

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 his/her 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 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.)

Studietype

Observasjonsmessig

Registrering (Forventet)

10000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Moscow, Den russiske føderasjonen, 121551
        • Rekruttering
        • Federal State Budgetary Institution NATIONAL MEDICAL CENTER CARDIOLOGY RESEARCH CENTER Ministry of Health of the Russian Federation
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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 .

The diagnosed patient was admitted to the hospital between days 1 and 10 of the current mont.

Exclusion Criteria:

1. A patient or his/her legal representative did not sign the IC.

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Tverrsnitt

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Monitoring of the patient
Tidsramme: 12 monthes
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
12 monthes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 12 monthes

Record the f- recurrent MI

  • heart failure
  • ischemic stroke
  • clinically significant bleeding
  • unplanned revascularisation post-discharge frequency of complications:
12 monthes

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Pevzner, Myasnikov Institute of Clinical Cardiology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2020

Primær fullføring (Forventet)

31. desember 2022

Studiet fullført (Forventet)

31. desember 2024

Datoer for studieregistrering

Først innsendt

17. august 2020

Først innsendt som oppfylte QC-kriteriene

17. august 2020

Først lagt ut (Faktiske)

20. august 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2022

Sist bekreftet

1. august 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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