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OpenTrials
Completed

NCT Number: NCT02374190

Relationship Between Primary Percutaneous Coronary Intervention, Door-to-balloon Times, and Mortality for Heart Attack Patients Across England

The degree to which elevated mortality associated with weekend or night-time hospital admissions reflects poorer quality of care ('off-hours effect') is a contentious issue. We examined if off-hours admissions for primary percutaneous coronary intervention (PPCI) were associated with higher adjusted mortality and estimated the extent to which potential differences in door-to-balloon (DTB) times-a key indicator of care quality for ST elevation myocardial infarction (STEMI) patients-could explain this association. Nationwide registry-based prospective observational study using Myocardial Ischemia National Audit Project data in England. We examined how off-hours admissions and DTB times were associated with our primary outcome measure, 30-day mortality, using hierarchical logistic regression models that adjusted for STEMI patient risk factors. In-hospital mortality was assessed as a secondary outcome. Our study found that higher adjusted mortality associated with off-hours admissions for PPCI could be partly explained by differences in DTB times.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London School of Economics and Political Science

London, WC2A2AE, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • STEMI patients admitted from 1 January 2007 to 31 December 2012
  • STEMI patients aged over 18 years
  • STEMI patients admitted directly to '24/7' PPCI-capable hospitals for PPCI
  • Discharge diagnosis of STEMI
  • Provision of PPCI based on initial reperfusion strategy

Exclusion criteria

  • Hospitals performing less than 20 procedures per year
  • Hospitals performing PPCIs only during regular hours
  • Interhospital transfers
  • PPCIs conducted within 6 hours on hospital arrival

Treatment and study plan

Standard Hospital Care

Other

We described patient characteristics using percentages for categorical data, means and SD or medians and IQRs for normally and non-normally distributed continuous variables, respectively. Statistical comparisons for differences in baseline characteristics among patients admitted during regular hours and off-hours were performed using χ2 tests for categorical variables, t-tests and Wilcoxon rank sum tests for normally and non-normally distributed continuous variables, respectively. DTB times were described using median and IQR based on time of admission. All p values were calculated as two-tailed analyses, using a significance level of 5%.

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days post-discharge

Secondary outcomes

  1. In-hospital mortality

    Time frame: Patient length of stay in hospital until discharge, an average of 3 days

Sponsors and collaborators

Lead sponsor

London School of Economics and Political Science

Other

Registry information

Official study title

The Relationship Between Off-hours Admissions for Primary Percutaneous Coronary Intervention, Door-to-balloon Time and Mortality for Patients With ST-elevation Myocardial Infarction in England: a Registry-based Prospective National Cohort Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2015
Registry last updated
May 1, 2020

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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