Myocardial InfarctionNCT02374190
Relationship Between Primary Percutaneous Coronary Intervention, Door-to-balloon Times, and Mortality for Heart Attack Patients Across England
An observational study of Myocardial Infarction, run by London School of Economics and Political Science at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Standard Hospital Care
- How many people
- 42,677 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 24 Dec 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of patients admitted to hospital in England for STEMI between 1 January 2007 and 31 December 2012.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Economics and Political Science
London, WC2A2AE
About this study
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
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.
- Conditions
- Myocardial Infarction
- Being tested
- Standard Hospital Care
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Hospital CareOther
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%.
| Study group | Role | What they receive |
|---|---|---|
| Hospital Admitted STEMI Patients | The analytical cohort for this study consisted of STEMI patients aged over 18 years admitted directly to '24/7' PPCI-capable hospitals for PPCI. STEMI patients were identified based on their discharge diagnoses and were selected as having received PPCI according to their initial reperfusion strategy. Hospitals performing only sporadic PPCI procedures, which we defined as less than 20 procedures per year, and only performing PPCIs during regular hours were not included in the analysis. Interhospital transfers were not included in the analysis, and we limited our analysis to PPCIs conducted within 6 hours on hospital arrival on the assumption that patients with a DTB time beyond this did not receive PCI as a primary reperfusion strategy. The analysis was conducted for the time period for which data were available-1 January 2007 to 31 December 2012. We conducted a complete-case analysis. Receives: Other: Standard Hospital Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 days post-discharge
Secondary outcomes (1)
In-hospital mortality
Measured: Patient length of stay in hospital until discharge, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start1 Sep 2017
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42,677 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias Mossialos, MD PhD, Principal investigator, London School of Economics and Political ScienceSebastian Salas-Vega, PhD, Principal investigator, London School of Economics and Political ScienceSahan Jayawardana, MSc, Study chair, London School of Economics and Political Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374190
- Sponsor's protocol ID
- LSEHE40914022015
- Status last verified
- Apr 2020
- First submitted
- 13 Feb 2015
- Last updated
- 1 May 2020
- Results posted
- No
- Individual data sharing
- No
Publications
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 England: a registry-based prospective national cohort study. BMJ Qual Saf. 2020 Jul;29(7):541-549. doi: 10.1136/bmjqs-2019-010067. Epub 2019 Dec 12.
PubMed 31831635
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02374190
- Acronym / sponsor ID
- LSEHE40914022015
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,677 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital Admitted STEMI Patients | – | Other: Standard Hospital CareThe analytical cohort for this study consisted of STEMI patients aged over 18 years admitted directly to '24/7' PPCI-capable hospitals for PPCI. STEMI patients were identified based on their discharge diagnoses and were selected as having received PPCI according to their initial reperfusion strategy. Hospitals performing only sporadic PPCI procedures, which we defined as less than 20 procedures per year, and only performing PPCIs during regular hours were not included in the analysis. Interhospital transfers were not included in the analysis, and we limited our analysis to PPCIs conducted within 6 hours on hospital arrival on the assumption that patients with a DTB time beyond this did not receive PCI as a primary reperfusion strategy. The analysis was conducted for the time period for which data were available-1 January 2007 to 31 December 2012. We conducted a complete-case analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of patients admitted to hospital in England for STEMI between 1 January 2007 and 31 December 2012.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Hospital CareWe 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%. | Other | Hospital Admitted STEMI Patients |
Primary outcome
30-day mortality
Time frame: 30 days post-discharge
1 secondary outcome
In-hospital mortality
Time frame: Patient length of stay in hospital until discharge, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Results publication: PubMed 31831635Jayawardana 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 England: a registry-based prospective national cohort study. BMJ Qual Saf. 2020 Jul;29(7):541-549. doi: 10.1136/bmjqs-2019-010067. Epub 2019 Dec 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Mossialos, MD PhD principal investigator
London School of Economics and Political Science
Sebastian Salas-Vega, PhD principal investigator
London School of Economics and Political Science
Sahan Jayawardana, MSc study chair
London School of Economics and Political Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by London School of Economics and Political Science at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020; AzTrials last refreshed its copy on 6 Nov 2026.