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

2 de agosto de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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.)

Tipo de estudio

De observación

Inscripción (Anticipado)

10000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Shakhnovich
  • Número de teléfono: +7 9037992718
  • Correo electrónico: shakhnovich@mail.ru

Ubicaciones de estudio

      • Moscow, Federación Rusa, 121551
        • Reclutamiento
        • Federal State Budgetary Institution NATIONAL MEDICAL CENTER CARDIOLOGY RESEARCH CENTER Ministry of Health of the Russian Federation
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Transversal

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Monitoring of the patient
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 12 monthes

Record the f- recurrent MI

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Pevzner, Myasnikov Institute of Clinical Cardiology

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2020

Finalización primaria (Anticipado)

31 de diciembre de 2022

Finalización del estudio (Anticipado)

31 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

17 de agosto de 2020

Primero enviado que cumplió con los criterios de control de calidad

17 de agosto de 2020

Publicado por primera vez (Actual)

20 de agosto de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

2 de agosto de 2022

Última verificación

1 de agosto de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AMI 05.2020

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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