Impact of Pre-Hospital and Hospital Delays on Myocardial Infarction Outcomes (PHHD-MI)

April 27, 2025 updated by: Abdul-Ilah R. Khamis, Al-Nahrain University

The Impact of Pre-Hospital and Hospital Delays on Myocardial Infarction Outcomes: A Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Recruiting
        • College of Medicine - Al-Nahrain University
        • Sub-Investigator:
          • Ahmed K. Elshehaby, Student
        • Contact:
        • Sub-Investigator:
          • Wissal Fatih Student
        • Sub-Investigator:
          • Maryem Filal Student
        • Sub-Investigator:
          • Alaa Hamza Lecturer
        • Sub-Investigator:
          • Rafal Abdulamir Abdullah Almaulla, M.B.CH.B
        • Principal Investigator:
          • Abdulillah R. Khamees

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients aged 18 years and older who are diagnosed with acute myocardial infarction (MI), either STEMI or NSTEMI, confirmed by clinical symptoms, electrocardiogram (ECG), and elevated cardiac biomarkers (e.g., troponin). Participants will be admitted to Al-Kadhimiya Teaching Hospital within 12 hours of symptom onset and will undergo reperfusion therapy, such as thrombolysis or percutaneous coronary intervention (PCI).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital Mortality
Time Frame: Up to discharge, an average of 7 days
percentage of patients who die during hospitalization following myocardial infarction.
Up to discharge, an average of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-Reperfusion Therapy
Time Frame: Pre-Hospital Delay: Average of 4 hours from symptom onset to first medical contact. Hospital Delay: Average of 2 hours from hospital admission to the initiation of reperfusion therapy.
The time (in minutes) from symptom onset to the initiation of reperfusion therapy (e.g., thrombolysis or percutaneous coronary intervention).
Pre-Hospital Delay: Average of 4 hours from symptom onset to first medical contact. Hospital Delay: Average of 2 hours from hospital admission to the initiation of reperfusion therapy.
Length of Hospital Stay
Time Frame: Up to discharge, an average of 7 days
The total duration of a patient's stay in the hospital, measured from the date of admission to the date of discharge.
Up to discharge, an average of 7 days
Major Adverse Cardiac Events (MACE)
Time Frame: Up to discharge, an average of 7 days
Includes recurrent myocardial infarction, heart failure, and arrhythmias occurring during hospitalization.
Up to discharge, an average of 7 days
Complication Rate
Time Frame: Up to discharge, an average of 7 days
The proportion of patients developing complications related to delays in treatment (e.g., cardiogenic shock, ventricular rupture).
Up to discharge, an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Nahrain University

Investigators

  • Study Director: Aws Al-Rubaye Lecturer, Internal Medicine, College Of Medicine - Nahrain University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNCOMIRB20241213A
  • 015 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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