Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Investigating Variation in Hospital Acute Coronary Syndrome Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oras Alabas, University of Leeds
ClinicalTrials.gov Identifier:
NCT01819103
First received: March 23, 2013
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care.


Condition
Acute Myocardial Infarction

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Evaluation of the Methods and Management of Acute Coronary Events-4: Investigating Variation in Hospital Acute Coronary Syndrome Outcomes

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug Adherence [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Health related quality of life assessement [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, Urine


Enrollment: 5555
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute myocardial infarction
Drug Adherence

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 depend 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, patient experience of hospital care and whether patients take their medication after discharge from hospital.

Notably, the challenges posed by poor drug adherence to secondary prevention medications are recognised by the World Health Organisation as the highest area of priority for improving individual health throughout the world. In addition, Patient Reported Outcome Measures (PROMs) are set to be the cornerstone of the evaluation of patient experiences of National Health Service quality of care.

Using 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 5555 consented patients were recruited from acute Trusts in England.

Criteria

Inclusion Criteria:

Age > 18 years, both sexes, acute admission to the acute Trust with suspected acute coronary syndrome (ACS).

Exclusion Criteria:

Patients at a terminal stage of any illness, and those in whom follow up would be inappropriate or impractical.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819103

Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Chris P Gale, PhD University of Leeds
  More Information

No publications provided

Responsible Party: Oras Alabas, Dr, University of Leeds
ClinicalTrials.gov Identifier: NCT01819103     History of Changes
Other Study ID Numbers: 12/WM/0431
Study First Received: March 23, 2013
Last Updated: April 3, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Leeds:
Mortality
Acute Myocardial Infarction
Drug Adherence
Drug Compliance
Health-related quality of life

Additional relevant MeSH terms:
Acute Coronary Syndrome
Infarction
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014