Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 2:09 PM
Study NCT ID:
NCT06925568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2025-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Profile, Management Strategies, And Outcome Of Patients With Acute Chest Pain In Regional Referral Hospitals In Tanzania. Protocol For A Prospective, Multi-Centre Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 317}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '30days'}], 'secondaryOutcomes': [{'measure': 'Management provided to ACS patients', 'timeFrame': '30days'}, {'measure': 'Time intervals taken from the initial hospital presentation to the initial management.', 'timeFrame': '30days'}, {'measure': "The occurrence of a major adverse cardiovascular event (MACE) within 30 days after the patient's initial presentation to the emergency department.", 'timeFrame': '30days', 'description': 'MACE is defined as any of the following: non-fatal myocardial infarction, urgent revascularization, stroke, cardiac arrest, or cardiogenic shock.'}, {'measure': 'ED readmission within 30 days after the initial visit.', 'timeFrame': '30days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Chest Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to understand how patients with acute chest pain are evaluated, treated, and cared for in emergency departments (EDs) at regional hospitals in Tanzania. Chest pain can be caused by many conditions, some of which are life-threatening, like heart attacks (acute coronary syndrome, or ACS). In Tanzania and other low-resource settings, delays in diagnosis and treatment can lead to poor outcomes. This study will document current practices, identify challenges, and link these findings to patient outcomes (e.g., survival, complications) to improve care for future patients.\n\n\\- Participants: Adults (18 years or older) who come to the ED with chest pain or suspected acute coronary syndrome (heart problem) at the regional referral hospitals in Dar es Salaam, Tanzania. Three regional referral hospitals and one specialized cardiac hospital (Jakaya Kikwete Cardiac Institute) will be involved in this study. Research assistants will collect data during routine care.\n\nDuring the study, i. Enrollment will take place over 12 months; 317 patients with chest pain will be invited to participate.\n\nii. Researchers will record:\n\n* How quickly patients receive initial diagnostic tests (e.g., ECG, blood tests for heart damage).\n* Treatments given (e.g., medications, procedures to restore blood flow to the heart).\n* Patient outcomes over 30 days (e.g., survival, readmission to the hospital, complications like another heart attack or stroke).\n\niii. Follow-up: Patients will be contacted by phone 30 days after their ED visit to check their health status.\n\nThis study is important because-: Chest pain is a common reason for ED visits, but in Tanzania, many patients face delays in diagnosis or lack access to lifesaving treatments. This study will identify gaps in care to help hospitals improve emergency services. Understanding the challenges in chest pain care can empower families to advocate for timely treatment for their loved ones. For Healthcare Providers: The findings will guide hospitals in adopting better protocols (e.g., faster ECGs, improved use of medications) and allocating resources effectively. For Policymakers: Results can inform national strategies to reduce deaths from heart disease in Tanzania.\n\nDuring the study, participants should know that there will be no changes to care; patients will receive the same care they would normally get. The study only observes and records what happens. Personal information will be kept confidential, and data will be anonymized (no names or identifiers used). Participation is voluntary, and patients can choose to join or refuse without affecting their care.\n\nKey Questions the Study Will Answer\n\n1. How quickly do patients with chest pain get critical tests (like ECGs) and treatments in Tanzanian hospitals?\n2. What are the most common barriers to timely care (e.g., lack of equipment, training gaps)?\n3. What percentage of patients survive 30 days after a chest pain episode, and what factors influence their outcomes? Potential Benefits\n\n * Improved Care: Findings may lead to better hospital protocols.\n * Resource Allocation: Highlight where hospitals need more tools (e.g., ECG machines) or medications\n * Global Impact: Lessons from Tanzania can help other low-resource countries improve emergency heart care.\n\nEthical Considerations\n\n* Approval: The study has been reviewed and approved by ethics committees to ensure patient safety and rights.\n* Informed Consent: Participants (or their families, if critically ill) will be asked for permission before joining.\n\nHow will results be shared-: Findings will be published in medical journals and shared with Tanzanian hospitals, health officials, and global organizations to drive improvements in emergency care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Nontraumatic patients with acute chest pain or suspected acute coronary syndrome (ACS) presenting to the ED at regional referral hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged eighteen years and above who present at the ED with nontraumatic acute chest pain or suspected acute coronary syndrome and who provided informed consent.\n\nExclusion Criteria:\n\n1. Patients with known lung cancer.\n2. Lost to follow-up\n3. The patient arrives in cardiac arrest.'}, 'identificationModule': {'nctId': 'NCT06925568', 'briefTitle': 'Clinical Profile, Management Strategies, And Outcome Of Patients With Acute Chest Pain In Regional Referral Hospitals In Tanzania. Protocol For A Prospective, Multi-Centre Cohort Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jakaya Kikwete Cardiac Institute'}, 'officialTitle': 'Clinical Profile, Management Strategies, And Outcome Of Patients With Acute Chest Pain In Regional Referral Hospitals In Tanzania. Protocol For A Prospective, Multi-Centre Cohort Study', 'orgStudyIdInfo': {'id': 'AB.123/307/01L/39'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients above 18yrs presenting with acute chest pain or Suspected Acute Coronary Syndrome (ACS).', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'This is an observational study, so there is no direct intervention. However, the study involves documenting and analyzing the existing management strategies, including\n\n* use of diagnostic tools ECG, troponin tests, etc\n* Administration of medications such as antiplates and anticoagulants.\n* Reperfusion therapies -thrombolysis, PCI', 'armGroupLabels': ['Patients above 18yrs presenting with acute chest pain or Suspected Acute Coronary Syndrome (ACS).']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jakaya Kikwete Cardiac Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Chiku Badru Mwimbo', 'investigatorAffiliation': 'Jakaya Kikwete Cardiac Institute'}}}}