Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-28 @ 11:23 PM
Study NCT ID:
NCT04520204
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National, Multi-center, Prospective, and Retrospective Cohort Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monitoring of the patient', 'timeFrame': '12 monthes', 'description': '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'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '12 monthes', 'description': 'Record the f- recurrent MI\n\n* heart failure\n* ischemic stroke\n* clinically significant bleeding\n* unplanned revascularisation post-discharge frequency of complications:'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': "National, multi-center, observational, prospective, and retrospective cohort study. The study does not provide for intervention in routine clinical practice.\n\nKey goals:\n\n• 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,\n\nand 6-12 months after the diagnosis establishment).\n\n* 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;\n* Assessment of patients' treatment adherence after 6 and 12 months.\n\nThe 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).\n\nRecruitment period: 2020-2022. Expected number of subjects: 10,000.", 'detailedDescription': "The Russian Registry of Acute Myocardial Infarction study is an independent study initiated by the investigators;\n\nThe 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;\n\nFor every engaged hospital (medical center) the investigators will designate a 2-3 person task team, including a Team Leader;\n\nThe participants shall be kept informed and coordinated via email and messengers. The website of the Russian Society of Emergency Cardiology.\n\nThe study will be hosted by the CRM Quinta® platform.\n\nAdministration, data entry monitoring, and statistical processing will be carried out by Aston Consulting (a certified personal data operator.)\n\nAO Aston Consulting has a license for storage and processing of personal data in accordance with the applicable legislation.\n\nPATIENTS.\n\nINCLUSION CRITERIA\n\n1\\. 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 .\n\nEXCLUSION CRITERIA\n\n1\\. A patient or his/her legal representative did not sign IC.\n\nSTUDY ASSESSMENTS\n\nThe following information will be collected and entered into CRF: Full name\n\nResidential address\n\nPhone number of patients or their legal representatives' Demographic profile. Weight, height\n\nSocial status (education, job title, occupation status)\n\nCo-morbidities\n\nClinical signs and symptoms\n\nDrug therapy.\n\nClinical outcomes during the hospital stay.\n\nDrug therapy and clinical outcomes in 6 and 12 months after the diagnosis establishment.\n\nHospitals wishing to join the study must contact any of the project coordinators and complete the Participation questionnaire (Appendix 4).\n\nThe 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.\n\nAt 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.\n\nShall the initiators have any questions regarding the entered data, they will ask the participants to elaborate, clarify, or correct the data.\n\nIf the patient dies before the enrolment to the study, his/her data shall be entered into the database retrospectively.\n\nThe 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.)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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 .\n\nThe diagnosed patient was admitted to the hospital between days 1 and 10 of the current mont.\n\nExclusion Criteria:\n\n1\\. A patient or his/her legal representative did not sign the IC.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04520204', 'acronym': 'REGION', 'briefTitle': 'National, Multi-center, Prospective, and Retrospective Cohort Study.', 'organization': {'class': 'OTHER', 'fullName': 'Healthy Future'}, 'officialTitle': 'Russian Registry of Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'AMI 05.2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '121551', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Shakhnovich', 'role': 'CONTACT', 'email': 'shakhnovich@mail.ru', 'phone': '+79037992718'}], 'facility': 'Federal State Budgetary Institution NATIONAL MEDICAL CENTER CARDIOLOGY RESEARCH CENTER Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Shakhnovich', 'role': 'CONTACT', 'email': 'shakhnovich@mail.ru', 'phone': '+7 9037992718'}], 'overallOfficials': [{'name': 'Pevzner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Myasnikov Institute of Clinical Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthy Future', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}