Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT06048003
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Armenian National Registry of Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of the in-hospital mortality', 'timeFrame': 'During 5 to 7 days of hospitalization', 'description': 'Determine the rate of the in-hospital mortality for the patients with STEMI admitted to the participating hospitals'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '30 days and 12 months', 'description': 'Compare short-term (30 days) and long-term (12 months) CV mortality depending on the management strategies.'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days and 12 months', 'description': 'Compare short-term (30 days) and long-term (12 months) all-cause mortality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI', 'Myocardial infarction', 'acute coronary syndrome', 'CV mortality', 'biobanking'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://armcardio.am/', 'label': 'Armenian Cardiologists Association official website'}]}, 'descriptionModule': {'briefSummary': 'This is a national, multicenter prospective observational study of patients presenting to hospitals in Armenia with STEMI diagnosis.\n\nThe main questions it aims to answer are:\n\n* Determine the rate of in-hospital mortality for the patients with STEMI admitted to the participating hospitals.\n* Compare short and long-term CV and all-cause mortality and hospitalization.\n* Determine how professional guidelines are followed in real-world situations.', 'detailedDescription': 'Although the state program on primary percutaneous coronary intervention in ST elevated myocardial infarction, which was launched in 2015 helped to drastically decrease STEMI mortality rates, patients who had survived usually develop heart failure (HF) which leads to increased economic burden for the Armenian healthcare system.\n\nThe total duration of the study will be 24 months. The target number of the inclusion is 2500 patients. The follow-up period for enrolled patients will be 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The pre-screened population will consist of all patients \\>18 years old presenting acutely with suspected STEMI in the participating hospitals.\n\nOnly patients with confirmed diagnosis of STEMI will be included in the registry, after informed consent signing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patient (≥ 18 years of age),\n2. Admitted to the participating centers for a STEMI within 48 hours of symptom onset: characterized by a rise and fall of cardiac markers (troponins) together with ST elevation in at least two contagious leads or LBBB.\n3. Have given signed informed consent to participate in the study.\n\nNon-Inclusion Criteria:\n\n1. MI occurring ≤ 48 hours after PCI or CABG\n2. The patient or the legal representative refused to sign the informed consent\n\nExclusion Criteria:\n\nWithdrawal of the informed consent'}, 'identificationModule': {'nctId': 'NCT06048003', 'acronym': 'ARMI', 'briefTitle': 'Armenian National Registry of Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Armenian Cardiologists Association'}, 'officialTitle': 'Armenian National Registry of ST-elevation Myocardial Infarction,a Multicenter Prospective Observational Study With Biocollection', 'orgStudyIdInfo': {'id': 'ACA-2023001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No specific intervention', 'type': 'OTHER', 'description': 'No specific intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vanadzor', 'state': 'Lori', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Inga Hovhannisyan', 'role': 'CONTACT'}], 'facility': 'Vanadzor Medical Center', 'geoPoint': {'lat': 40.8074, 'lon': 44.49704}}, {'city': 'Gyumri', 'state': 'Shirak', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Arthur Stepanyan', 'role': 'CONTACT'}], 'facility': 'Gyumri Medical Center', 'geoPoint': {'lat': 40.79305, 'lon': 43.84635}}, {'city': 'Goris', 'state': 'Syunik', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Shahane Musayelyan', 'role': 'CONTACT'}], 'facility': 'French-Armenian Cardiovascular Center', 'geoPoint': {'lat': 39.51111, 'lon': 46.34168}}, {'zip': '0025', 'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Hamayak S Sisakyan', 'role': 'CONTACT'}], 'facility': 'Heratsi Hospital Complex N1', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'zip': '0087', 'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Hamlet G Hayrapetyan', 'role': 'CONTACT'}], 'facility': 'Erebouni Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Narek Atoyan', 'role': 'CONTACT'}], 'facility': 'Aramyants Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Mayranush Drambyan', 'role': 'CONTACT'}], 'facility': 'Armenia Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Zara Kartoyan', 'role': 'CONTACT'}], 'facility': 'Astghik Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Serob Manukian', 'role': 'CONTACT'}], 'facility': 'Best Life Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Mikael Adamyan', 'role': 'CONTACT'}], 'facility': 'Nork Marash Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Tigran Astvatsatryan', 'role': 'CONTACT'}], 'facility': 'Shengavit Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Irina Hovhannisyan', 'role': 'CONTACT'}], 'facility': 'Surb Grigor Lusavorich Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Hovhannes Kzhdryan', 'role': 'CONTACT'}], 'facility': 'Yerevan Scientific Medical Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'centralContacts': [{'name': 'Hamlet G Hayrapetyan, Prof.', 'role': 'CONTACT', 'email': 'cardioerebouni@yahoo.com', 'phone': '+37493555050'}, {'name': 'Hripsime V Poghosyan, Dr.', 'role': 'CONTACT', 'email': 'hripsime.poghosyan@santearmenie.org', 'phone': '+37477234994'}], 'overallOfficials': [{'name': 'Hamlet G Hayrapetyan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armenian Cardiologists Association'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armenian Cardiologists Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'Santé Arménie French-Armenian Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}