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

NCT06738498 | Recruiting DMC

• 2 other identifiers: UNCOMIRB20241213A015
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction (MI)

Keywords

Myocardial Infarction; Pre-Hospital Delay; Hospital Delay; Reperfusion Therapy; Patient Outcomes; Mortality; Time-to-Treatment; Cardiovascular Emergency

Outcome Measures

Primary Outcomes (1)

• In-hospital Mortality

  percentage of patients who die during hospitalization following myocardial infarction.

  Up to discharge, an average of 7 days

Secondary Outcomes (4)

• Time-to-Reperfusion Therapy

  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

  Up to discharge, an average of 7 days

• Major Adverse Cardiac Events (MACE)

  Up to discharge, an average of 7 days

• Complication Rate

  Up to discharge, an average of 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

RECRUITING

Related Publications (11)

• Shehab A, AlHabib KF, Bhagavathula AS, Hersi A, Alfaleh H, Alshamiri MQ, Ullah A, Sulaiman K, Almahmeed W, Al Suwaidi J, Alsheikh-Ali AA, Amin H, Al Jarallah M, Salam AM. Clinical Presentation, Quality of Care, Risk Factors and Outcomes in Women with Acute ST-Elevation Myocardial Infarction (STEMI): An Observational Report from Six Middle Eastern Countries. Curr Vasc Pharmacol. 2019;17(4):388-395. doi: 10.2174/1570161116666180315104820.

  PMID: 29542414 BACKGROUND

• Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. doi: 10.1016/S0140-6736(96)07492-2.

  PMID: 9167458 BACKGROUND

• GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1459-1544. doi: 10.1016/S0140-6736(16)31012-1.

  PMID: 27733281 BACKGROUND

• Ladwig KH, Fang X, Wolf K, Hoschar S, Albarqouni L, Ronel J, Meinertz T, Spieler D, Laugwitz KL, Schunkert H. Comparison of Delay Times Between Symptom Onset of an Acute ST-elevation Myocardial Infarction and Hospital Arrival in Men and Women <65 Years Versus >/=65 Years of Age.: Findings From the Multicenter Munich Examination of Delay in Patients Experiencing Acute Myocardial Infarction (MEDEA) Study. Am J Cardiol. 2017 Dec 15;120(12):2128-2134. doi: 10.1016/j.amjcard.2017.09.005. Epub 2017 Sep 18.

  PMID: 29122276 RESULT

• Peng YG, Feng JJ, Guo LF, Li N, Liu WH, Li GJ, Hao G, Zu XL. Factors associated with prehospital delay in patients with ST-segment elevation acute myocardial infarction in China. Am J Emerg Med. 2014 Apr;32(4):349-55. doi: 10.1016/j.ajem.2013.12.053. Epub 2014 Jan 3.

  PMID: 24512889 RESULT

• Naegeli B, Radovanovic D, Rickli H, Erne P, Seifert B, Duvoisin N, Pedrazzini G, Urban P, Bertel O. Impact of a nationwide public campaign on delays and outcome in Swiss patients with acute coronary syndrome. Eur J Cardiovasc Prev Rehabil. 2011 Apr;18(2):297-304. doi: 10.1177/1741826710389386. Epub 2011 Feb 11.

  PMID: 21450676 RESULT

• Park YH, Kang GH, Song BG, Chun WJ, Lee JH, Hwang SY, Oh JH, Park K, Kim YD. Factors related to prehospital time delay in acute ST-segment elevation myocardial infarction. J Korean Med Sci. 2012 Aug;27(8):864-9. doi: 10.3346/jkms.2012.27.8.864. Epub 2012 Jul 25.

  PMID: 22876051 RESULT

• Sullivan AL, Beshansky JR, Ruthazer R, Murman DH, Mader TJ, Selker HP. Factors associated with longer time to treatment for patients with suspected acute coronary syndromes: a cohort study. Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):86-94. doi: 10.1161/CIRCOUTCOMES.113.000396. Epub 2014 Jan 14.

  PMID: 24425697 RESULT

• Lee SH, Kim HK, Jeong MH, Lee JM, Gwon HC, Chae SC, Seong IW, Park JS, Chae JK, Hur SH, Cha KS, Kim HS, Seung KB, Rha SW, Ahn TH, Kim CJ, Hwang JY, Choi DJ, Yoon J, Joo SJ, Hwang KK, Kim DI, Oh SK; KAMIR Investigators. Pre-hospital delay and emergency medical services in acute myocardial infarction. Korean J Intern Med. 2020 Jan;35(1):119-132. doi: 10.3904/kjim.2019.123. Epub 2019 Nov 28.

  PMID: 31766823 RESULT

• George L, Ramamoorthy L, Satheesh S, Saya RP, Subrahmanyam DK. Prehospital delay and time to reperfusion therapy in ST elevation myocardial infarction. J Emerg Trauma Shock. 2017 Apr-Jun;10(2):64-69. doi: 10.4103/0974-2700.201580.

  PMID: 28367010 RESULT

• De Luca G, Suryapranata H, Ottervanger JP, Antman EM. Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts. Circulation. 2004 Mar 16;109(10):1223-5. doi: 10.1161/01.CIR.0000121424.76486.20. Epub 2004 Mar 8.

  PMID: 15007008 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Aws Al-Rubaye Lecturer, Internal Medicine

  College Of Medicine - Nahrain University

  STUDY DIRECTOR

Central Study Contacts

Abdulillah R. Khamees

CONTACT

+9647838571013; allaabed987@ced.nahrainuniv.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 17, 2024
• Study Start: February 20, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 20, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)