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Acute Chest PainNCT06925568

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

An observational study of Acute Chest Pain, run by Jakaya Kikwete Cardiac Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Chest Pain
How many people
317 participants
Where
No sites listed yet
Study dates
1 May 2025to 30 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Nontraumatic patients with acute chest pain or suspected acute coronary syndrome (ACS) presenting to the ED at regional referral hospitals.

Who may be able to join

  • 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.

Who cannot join

  • Patients with known lung cancer.
  • Lost to follow-up
  • The patient arrives in cardiac arrest.

About this study

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.

  • 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.
Read more

During the study, i. Enrollment will take place over 12 months; 317 patients with chest pain will be invited to participate.

ii. Researchers will record:

  • How quickly patients receive initial diagnostic tests (e.g., ECG, blood tests for heart damage).
  • Treatments given (e.g., medications, procedures to restore blood flow to the heart).
  • Patient outcomes over 30 days (e.g., survival, readmission to the hospital, complications like another heart attack or stroke). iii. Follow-up: Patients will be contacted by phone 30 days after their ED visit to check their health status.

This 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.

During 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.

Key Questions the Study Will Answer

  1. How quickly do patients with chest pain get critical tests (like ECGs) and treatments in Tanzanian hospitals?
  2. What are the most common barriers to timely care (e.g., lack of equipment, training gaps)?
  3. What percentage of patients survive 30 days after a chest pain episode, and what factors influence their outcomes? Potential Benefits
  • Improved Care: Findings may lead to better hospital protocols.
  • Resource Allocation: Highlight where hospitals need more tools (e.g., ECG machines) or medications
  • Global Impact: Lessons from Tanzania can help other low-resource countries improve emergency heart care.

Ethical Considerations

  • Approval: The study has been reviewed and approved by ethics committees to ensure patient safety and rights.
  • Informed Consent: Participants (or their families, if critically ill) will be asked for permission before joining.

How 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.

Being tested
No Intervention: Observational Cohort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    This is an observational study, so there is no direct intervention. However, the study involves documenting and analyzing the existing management strategies, including

    • use of diagnostic tools ECG, troponin tests, etc
    • Administration of medications such as antiplates and anticoagulants.
    • Reperfusion therapies -thrombolysis, PCI
Study groups in NCT06925568
Study groupRoleWhat they receive
Patients above 18yrs presenting with acute chest pain or Suspected Acute Coronary Syndrome (ACS).Not described
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all-cause mortality

    Measured: 30days

Secondary outcomes (4)
  1. Management provided to ACS patients

    Measured: 30days

  2. Time intervals taken from the initial hospital presentation to the initial management.

    Measured: 30days

  3. The occurrence of a major adverse cardiovascular event (MACE) within 30 days after the patient's initial presentation to the emergency department.

    MACE is defined as any of the following: non-fatal myocardial infarction, urgent revascularization, stroke, cardiac arrest, or cardiogenic shock.

    Measured: 30days

  4. ED readmission within 30 days after the initial visit.

    Measured: 30days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
317 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925568
Sponsor's protocol ID
AB.123/307/01L/39
Status last verified
Apr 2025
First submitted
7 Apr 2025
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Chest Pain, run by Jakaya Kikwete Cardiac Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all-cause mortality (time frame: 30days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

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