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Investigating Variation in Hospital Acute Coronary Syndrome Outcomes

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ClinicalTrials.gov Identifier: NCT01808027
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Oras Alabas, University of Leeds

Tracking Information
First Submitted Date March 7, 2013
First Posted Date March 8, 2013
Last Update Posted Date March 8, 2013
Study Start Date February 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2013)
delays to treatment [ Time Frame: 12 months ]
Quantification of hospital attributable effects relating to early and late mortality
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 7, 2013)
Describing trajectories of quality of life recovery patterns [ Time Frame: 12 month ]
Describing trajectories of quality of life recovery patterns
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
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.
Condition Acute Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts Acute myocardial infarction
patient with suspected acute coronary syndrome (ACS).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 7, 2013)
5555
Original Actual Enrollment Same as current
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01808027
Other Study ID Numbers 10/H1313/74
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Oras Alabas, University of Leeds
Original Responsible Party Same as current
Current Study Sponsor University of Leeds
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Chris P Gale, PhD University of Leeds
PRS Account University of Leeds
Verification Date March 2013