Investigating Variation in Hospital Acute Coronary Syndrome Outcomes

• ClinicalTrials.gov Identifier: NCT01808027
• Recruitment Status: Completed
• First Posted: March 8, 2013
• Last Update Posted: March 8, 2013
• Sponsor: University of Leeds
• 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 *

• Dondo TB, Munyombwe T, Hall M, Hurdus B, Soloveva A, Oliver G, Aktaa S, West RM, Hall AS, Gale CP. Sex differences in health-related quality of life trajectories following myocardial infarction: national longitudinal cohort study. BMJ Open. 2022 Nov 8;12(11):e062508. doi: 10.1136/bmjopen-2022-062508.
• Munyombwe T, Dondo TB, Aktaa S, Wilkinson C, Hall M, Hurdus B, Oliver G, West RM, Hall AS, Gale CP. Association of multimorbidity and changes in health-related quality of life following myocardial infarction: a UK multicentre longitudinal patient-reported outcomes study. BMC Med. 2021 Sep 28;19(1):227. doi: 10.1186/s12916-021-02098-y.
• Hurdus B, Munyombwe T, Dondo TB, Aktaa S, Oliver G, Hall M, Doherty P, Hall AS, Gale CP. Association of cardiac rehabilitation and health-related quality of life following acute myocardial infarction. Heart. 2020 Nov;106(22):1726-1731. doi: 10.1136/heartjnl-2020-316920. Epub 2020 Aug 21.
• Munyombwe T, Hall M, Dondo TB, Alabas OA, Gerard O, West RM, Pujades-Rodriguez M, Hall A, Gale CP. Quality of life trajectories in survivors of acute myocardial infarction: a national longitudinal study. Heart. 2020 Jan;106(1):33-39. doi: 10.1136/heartjnl-2019-315510. Epub 2019 Nov 7.
• Alabas OA, West RM, Gillott RG, Khatib R, Hall AS, Gale CP; EMMACE-3 Investigators. Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-3: protocol for a longitudinal study. BMJ Open. 2015 Jun 23;5(6):e006256. doi: 10.1136/bmjopen-2014-006256.

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

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