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History of Changes for Study: NCT01808027
Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
Latest version (submitted March 7, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 7, 2013 None (earliest Version on record)
Comparison Format:

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Study NCT01808027
Submitted Date:  March 7, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 10/H1313/74
Brief Title: Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
Official Title: Evaluation of the Methods and Management of Acute Coronary Events: 3. Investigating Variation in Hospital Acute Coronary Syndrome Outcomes
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2013
Overall Status: Completed
Study Start: February 2011
Primary Completion: February 2013 [Actual]
Study Completion: February 2013 [Actual]
First Submitted: March 7, 2013
First Submitted that
Met QC Criteria:
March 7, 2013
First Posted: March 8, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 7, 2013
Last Update Posted: March 8, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Leeds
Responsible Party: Principal Investigator
Investigator: Oras Alabas
Official Title: Dr
Affiliation: University of Leeds
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care.
Detailed Description: Over the last few years the chance of dying from a heart attack in England and Wales has reduced dramatically. Even so, there remain huge differences in mortality between hospitals. For example, up to a third of patients with a heart attack who attend hospitals in England are more likely to die than would be expected. That is, the type of treatment and the risk of death depends upon where a patient lives and which hospital they attend. In part, the variation in death may be due to the services available at the hospital or to factors such as socioeconomic deprivation. It may also relate to other factors such as depression, cardiac rehabilitation and whether patients take their medication after discharge from hospital. Using powerful statistical approaches that include measures of quality of life, we propose to examine data about heart attacks in England and investigate the 'postcode lottery of care'. Our aim, using regional data about heart attacks is to identify and measure the effects of hospital care. This research will identify hospital qualities that promote improved patient care. In doing so, best practice will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.
Open or close this module Conditions
Conditions: Acute Myocardial Infarction
Keywords: quality of life drug adherence drug compliance mortality
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Blood
Enrollment: 5555 [Actual]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 12 Months
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Acute myocardial infarction
patient with suspected acute coronary syndrome (ACS).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. delays to treatment
[ Time Frame: 12 months ]

Quantification of hospital attributable effects relating to early and late mortality
Secondary Outcome Measures:
1. Describing trajectories of quality of life recovery patterns
[ Time Frame: 12 month ]

Describing trajectories of quality of life recovery patterns
Other Outcome Measures:
1. Develop a risk score and a near-point risk Acute Coronary Syndrome model
[ Time Frame: two years ]

Develop a risk score and a near-point risk Acute Coronary Syndrome model
Open or close this module Eligibility
Study Population: Consented patients with acute coronary syndrome were recruited from acute Trusts in England. These hospitals have been selected because of their diverse population demographics, different acute coronary syndrome care pathways and established track record for good data collection. Specifically these hospitals represent both teaching hospitals and community hospitals - but more importantly include a wide range of patient types. Mortality tracked through the UK statistics authority, and primary and secondary endpoints tracked locally and transferred through the secure NHS net to a central database.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age > 18 years
  • Both sexes
  • Acute admission to the acute Trust with suspected acute coronary syndrome

Exclusion Criteria:

  • Patients at a terminal stage of any illness
  • Those in whom follow up would be inappropriate or impractical
Open or close this module Contacts/Locations
Study Officials: Chris P Gale, PhD
Principal Investigator
University of Leeds
Locations: United Kingdom, West Yorkshire
University of Leeds
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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