- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04520204
National, Multi-center, Prospective, and Retrospective Cohort Study. (REGION)
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Shakhnovich
- Numero di telefono: +7 9037992718
- Email: shakhnovich@mail.ru
Luoghi di studio
-
-
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Moscow, Federazione Russa, 121551
- Reclutamento
- Federal State Budgetary Institution NATIONAL MEDICAL CENTER CARDIOLOGY RESEARCH CENTER Ministry of Health of the Russian Federation
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Contatto:
- Shakhnovich
- Numero di telefono: +79037992718
- Email: shakhnovich@mail.ru
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Trasversale
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Monitoring of the patient
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 12 monthes
|
Record the f- recurrent MI
|
12 monthes
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pevzner, Myasnikov Institute of Clinical Cardiology
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AMI 05.2020
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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