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NCT Number: NCT06738498

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Medicine - Al-Nahrain University

Baghdad, Iraq

Location status: Recruiting

Location contact

Abdulillah R. Khamees

PRINCIPAL_INVESTIGATOR

Ahmed K. Elshehaby, Student

SUB_INVESTIGATOR

Alaa Hamza Lecturer

SUB_INVESTIGATOR

Aws Al-Rubaye Lecturer, Internal Medicine

CONTACT

[email protected]

+9647730288897

Maryem Filal Student

SUB_INVESTIGATOR

Rafal Abdulamir Abdullah Almaulla, M.B.CH.B

SUB_INVESTIGATOR

Wissal Fatih Student

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. In-hospital Mortality

    Time frame: Up to discharge, an average of 7 days

    percentage of patients who die during hospitalization following myocardial infarction.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulillah R. Khamees

CONTACT

[email protected]

+9647838571013

Sponsors and collaborators

Lead sponsor

Al-Nahrain University

Other

Registry information

Official study title

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

Acronym: PHHD-MI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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