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

Myocardial Infarction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374190
• Other study ID #: LSEHE40914022015
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 24, 2019

Study information

• Verified date: April 2020
• Source: London School of Economics and Political Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42677
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Standard Hospital Care
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 ?2 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%.

Locations

Country	Name	City	State
United Kingdom	London School of Economics and Political Science	London

Sponsors (1)

Lead Sponsor	Collaborator
London School of Economics and Political Science

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Jayawardana S, Salas-Vega S, Cornehl F, Krumholz HM, Mossialos E. 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 Engl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality		30 days post-discharge
Secondary	In-hospital mortality		Patient length of stay in hospital until discharge, an average of 3 days