Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-12 @ 11:09 PM
Study NCT ID:
NCT06535503
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Outcomes Among STEMI Patients With Cardiogenic Shock at Abu Dhabi City
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analyze STEMI patient with CS disease profile', 'timeFrame': '5 years', 'description': 'Comorbidities, demographical information, past medical history, morbidity'}, {'measure': 'Incidence of CS-complicated AMI events', 'timeFrame': '5 years', 'description': 'The incidence of CS-complicated AMI events will show an increase over the years because of advanced diagnostic modalities and a clearer definition of CS.'}, {'measure': 'Analyze treatment outcomes in the targeted population as per the patient profile', 'timeFrame': '5 years', 'description': 'Incidence of Mortality'}, {'measure': 'Analyze STEMI patient with CS disease profile', 'timeFrame': '5 years', 'description': 'Incidence of Morbidity'}, {'measure': 'Analyze treatment outcomes', 'timeFrame': '5 years', 'description': '% of patients who were discharged'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI', 'Cardiogenic Shock', 'Morbidity', 'Mortality'], 'conditions': ['ST Elevation Myocardial Infarction', 'Cardiogenic Shock']}, 'referencesModule': {'references': [{'pmid': '31208354', 'type': 'BACKGROUND', 'citation': 'Al-Shamsi S, Regmi D, Govender RD. Incidence of cardiovascular disease and its associated risk factors in at-risk men and women in the United Arab Emirates: a 9-year retrospective cohort study. BMC Cardiovasc Disord. 2019 Jun 17;19(1):148. doi: 10.1186/s12872-019-1131-2.'}, {'pmid': '30335314', 'type': 'BACKGROUND', 'citation': 'Akbar H, Mountfort S. Acute ST-Segment Elevation Myocardial Infarction (STEMI). 2024 Oct 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532281/'}, {'pmid': '26339723', 'type': 'BACKGROUND', 'citation': 'De Luca L, Olivari Z, Farina A, Gonzini L, Lucci D, Di Chiara A, Casella G, Chiarella F, Boccanelli A, Di Pasquale G, De Servi S, Bovenzi FM, Gulizia MM, Savonitto S. Temporal trends in the epidemiology, management, and outcome of patients with cardiogenic shock complicating acute coronary syndromes. Eur J Heart Fail. 2015 Nov;17(11):1124-32. doi: 10.1002/ejhf.339. Epub 2015 Sep 4.'}, {'pmid': '7642857', 'type': 'BACKGROUND', 'citation': 'Holmes DR Jr, Bates ER, Kleiman NS, Sadowski Z, Horgan JH, Morris DC, Califf RM, Berger PB, Topol EJ. Contemporary reperfusion therapy for cardiogenic shock: the GUSTO-I trial experience. The GUSTO-I Investigators. Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries. J Am Coll Cardiol. 1995 Sep;26(3):668-74. doi: 10.1016/0735-1097(95)00215-p.'}, {'pmid': '36816794', 'type': 'BACKGROUND', 'citation': 'Shalaby G, Niazi AK, Khaled S. Cardiogenic Shock Among Patients with Acute ST-Segment Elevation Myocardial Infarction in a Middle Eastern Country: A Single-Center Experience. J Saudi Heart Assoc. 2023 Jan 20;34(4):232-240. doi: 10.37616/2212-5043.1323. eCollection 2022.'}, {'pmid': '26271552', 'type': 'BACKGROUND', 'citation': 'Yusufali A, Bazargani N, Muhammed K, Gabroun A, AlMazrooei A, Agrawal A, Al-Mulla A, Hajat C, Baslaib F, Philip J, Gupta P, Bakir S, Krishnan S, Almahmeed W, Alsheikh-Ali A. Opportunistic Screening for CVD Risk Factors: The Dubai Shopping for Cardiovascular Risk Study (DISCOVERY). Glob Heart. 2015 Dec;10(4):265-72. doi: 10.1016/j.gheart.2015.04.008. Epub 2015 Aug 11.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/books/NBK482255/', 'label': 'Kosaraju, A., Pendela, V. S., \\& Hai, O. (2023, April 7). Cardiogenic shock. StatPearls \\[Internet\\]. https://www.ncbi.nlm.nih.gov/books/NBK482255/'}, {'url': 'https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-023-03165-3', 'label': 'High prevalence of cardiometabolic risk factors amongst young adults in the United Arab Emirates: The UAE Healthy Future Study.'}]}, 'descriptionModule': {'briefSummary': 'A retrospective study on the clinical characteristics and treatment outcomes of patients admitted with ST-elevation Myocardial Infarction (STEMI) complicated with cardiogenic shock (CS) during admission or CS development during their hospital stay for two tertiary hospitals in Abu Dhabi, UAE, from 2020-2024.', 'detailedDescription': "Cardiovascular disease (CVD) accounts for 40% of mortality in the UAE, which is higher than the global average. Long-term trends, incidence studies, and best practice guidance on Cardiogenic Shock (CS) with ST-elevation Myocardial infarction (STEMI) in the United Arab Emirates (UAE) and the Gulf Cooperation Council (GCC) are limited.\n\nThrough this retrospective study, investigators aim to identify treatment modalities and trends, hospitalization events, and patient demographics and comorbidities which lead to participant recovery or mortality in Sheikh Khalifa Medical City (SKMC) and Sheikh Shakhbout Medical City (SSMC) tertiary hospitals for patients admitted with STEMI and CS or developed CS after hospitalization with STEMI during January 2020-January 2024.\\[200-400 participants\\]. Data will be collected from eligible patients' electronic medical records (EMR)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with STEMI complicated by cardiogenic shock on admission or after hospitalization were treated in Abu Dhabi city from January 2020 to January 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18.\n* STEMI complicated by cardiogenic shock.\n* Were hospitalized or treated at SSMC or SKMC for STEMI complicated by cardiogenic shock.\n* Patient admitted between January 2019 to March 2024.\n\nExclusion Criteria:\n\n* Age less than 18.\n* Shock patient not related to Myocardial infarction.\n* NSTEMI-related cardiogenic shock.\n* Patients who were not treated at SSMC or SKMC for the STEMI complicated by cardiogenic shock.\n* Patient not admitted between January 2019 to March 2024.'}, 'identificationModule': {'nctId': 'NCT06535503', 'briefTitle': 'Clinical Characteristics and Outcomes Among STEMI Patients With Cardiogenic Shock at Abu Dhabi City', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Abu Dhabi Health Services Company'}, 'officialTitle': 'Clinical Characteristics and Outcomes Among ST-elevation Myocardial Infarction (STEMI) Patients With Cardiogenic Shock at Abu Dhabi City', 'orgStudyIdInfo': {'id': 'SEHAResearch ID 747'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with STEMI & Cardiogenic Shock', 'description': 'Patients with STEMI complicated by cardiogenic shock on admission or after hospitalization treated at SKMC \\& SSMC, Abu Dhbai'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11001', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Abdulmajeed BS Alzubaidi, MD', 'role': 'CONTACT', 'email': 'aalzubaidi@seha.ae', 'phone': '0502900663'}, {'name': 'Alina Naeem, MD', 'role': 'CONTACT', 'email': 'alnaeem@seha.ae', 'phone': '0566089799'}, {'name': 'Babiker MB Elsiraj, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abdulmajeed BS Alzubaidi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammed El Khazendar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yousef S Alabrach, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alina Naeem, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheikh Khalifa Medical City (SKMC)', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'zip': '11001', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Abdulmajeed BS Alzubaidi, MD', 'role': 'CONTACT', 'email': 'aalzubaidi@seha.ae', 'phone': '0502900663'}, {'name': 'Babiker MB Elsiraj, MD', 'role': 'CONTACT', 'email': 'Belsiraj@seha.ae', 'phone': '0564972830'}, {'name': 'Babiker MB Elsiraj, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abdulmajeed BS Alzubaidi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammed El Khazendar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yousef S Alabrach, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alina Naeem, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheikh Shakhbout Medical City (SKMC)', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Alina Naeem, MBBS', 'role': 'CONTACT', 'email': 'alnaeem@seha.ae', 'phone': '0097124102534'}, {'name': 'Babiker Babiker Mohamed Babiker Elsiraj MB Elsiraj, MD', 'role': 'CONTACT', 'email': 'Belsiraj@seha.ae', 'phone': '0564972830'}], 'overallOfficials': [{'name': 'Abdulmajeed BS Alzubaidi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abu Dhabi Health Services Co. -SEHA'}, {'name': 'Babiker Babiker Mohamed Babiker Elsiraj MB Elsiraj', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheikh Shakhbout Medical City'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The data will be available for 5 years after the analysis is completed', 'ipdSharing': 'YES', 'description': 'The plan is to share the clinical study report with all researchers. We will share the study protocol and case report form if further collaboration is decided while expanding our study.', 'accessCriteria': 'REDCap or PI \\& Facility Permission'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abu Dhabi Health Services Company', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sheikh Shakhbout Medical City', 'class': 'OTHER'}, {'name': 'Sheikh Khalifa Medical City', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Cardiology Specialist/Fellow at Sheikh Shakhbout Medical City', 'investigatorFullName': 'Babiker Mohamed Babiker Elsiraj', 'investigatorAffiliation': 'Abu Dhabi Health Services Company'}}}}