Impact of Pre-Hospital and Hospital Delays on Myocardial Infarction Outcomes

NCT ID: NCT06738498

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-12-20

Brief Summary

The goal of this prospective observational study is to investigate the impact of pre-hospital and hospital delays on the outcomes of myocardial infarction (MI) patients admitted to Al-Kadhimiya Teaching Hospital, Baghdad.

The main questions it aims to answer are:

How do pre-hospital delays (e.g., patient transport and first medical contact) affect clinical outcomes such as mortality, complication rates, and recovery time in MI patients? What is the influence of hospital-related delays (e.g., time to intervention or reperfusion therapy) on the prognosis of MI patients?

Participants will:

Be monitored for the time elapsed from symptom onset to first medical contact and subsequent time intervals during hospital care.

Have their clinical outcomes, including in-hospital mortality, length of stay, and post-intervention complications, recorded and analyzed.

Detailed Description

Myocardial infarction (MI) continues to be one of the leading causes of cardiovascular mortality globally, with outcomes highly dependent on the timeliness of treatment. Early reperfusion therapy is crucial for reducing mortality and minimizing long-term complications such as heart failure and arrhythmias. The impact of delayed treatment, both in the pre-hospital and hospital phases, is well documented, with longer delays significantly worsening clinical outcomes, particularly in terms of mortality and myocardial damage. Meanwhile, recent studies indicate that time delays to care among patients with STEMI (ST-segment elevation myocardial infarction) exist universally, showing a worse situation in low- and middle-income countries than in high-income countries.

Hospital and pre-hospital delays are critical determinants of MI outcomes. Factors contributing to pre-hospital delays include patient-related issues, such as lack of recognition of symptoms, misinterpretation of their severity, and delays in decision-making, as well as external factors like geographical barriers to healthcare facilities and limited access to emergency medical services. Based on these findings, some national or regional programs have been initiated to reduce the delays by targeting at controlling these factors through educational campaigns, implementation of prehospital ECG, establishing regional collaborative networks, and these actions have turned out to be effective.

Additional contributing factors are also evident, including administrative inefficiencies, delays in diagnosis, and challenges in accessing specialized care such as percutaneous coronary intervention or thrombolysis. Evidence suggests that prolonged hospital delays increase the risk of adverse clinical outcomes, including higher rates of mortality and heart failure.

Previous studies have highlighted the significant influence of time on patient recovery. Research has shown that early reperfusion therapy, such as thrombolysis or percutaneous coronary intervention, can significantly improve patient survival and reduce the risk of long-term complications. However, despite extensive global studies, there is limited research that focuses on the unique delays encountered in Middle Eastern and low-resource settings like Iraq. The healthcare challenges in these regions, including access to timely emergency services and hospital readiness, require further investigation to provide actionable insights.

In Iraq, particularly in Baghdad, the impact of pre-hospital and hospital delays on MI outcomes remains underexplored. While cardiovascular diseases, including MI, are prevalent, the healthcare system faces significant challenges, such as limited public awareness, inadequate pre-hospital care, and hospital system constraints. These factors may contribute to substantial delays in MI treatment, but their specific impact on patient outcomes has not been well studied. This research aims to fill this gap by conducting a prospective observational study at Al-Kadhimiya Teaching Hospital in Baghdad, assessing the extent of pre-hospital and hospital delays in the management of MI and their correlation with clinical outcomes. The study seeks to identify critical delays and propose recommendations for improving the timeliness of MI care in Iraq.

Conditions

Myocardial Infarction (MI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients who provide informed consent (or a legal representative provides consent if the patient is unable to do so).
• Patients who undergo reperfusion therapy, such as thrombolysis or percutaneous coronary intervention (PCI).
• Patients admitted to Al-Kadhimiya Teaching Hospital within 12 hours of symptom onset.

Exclusion Criteria

• Patients with non-acute myocardial infarction (e.g., stable angina, prior MI).
• Patients with severe comorbidities (e.g., advanced cancer, end-stage renal disease) that may complicate outcome assessments or interfere with treatment protocols.
• Patients who are transferred to another facility before reperfusion therapy is initiated.
• Pregnant women or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Nahrain University

OTHER

Sponsor Role: lead

Responsible Party

Abdul-Ilah R. Khamis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aws Al-Rubaye Lecturer, Internal Medicine

Role: STUDY_DIRECTOR

College Of Medicine - Nahrain University

Locations

College of Medicine - Al-Nahrain University

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Abdulillah R. Khamees

Role: CONTACT

allaabed987@ced.nahrainuniv.edu.iq

+9647838571013

Facility Contacts

Aws Al-Rubaye Lecturer, Internal Medicine

Role: primary

awsalrubaye@nahrainuniv.edu.iq

+9647730288897

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Other Identifiers

015

Identifier Type: OTHER

Identifier Source: secondary_id

UNCOMIRB20241213A

Identifier Type: -

Identifier Source: org_study_id