NCT01808027

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,555

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

March 7, 2013

Last Update Submit

March 7, 2013

Conditions

Acute Myocardial Infarction

Keywords

quality of life drug adherence drug compliance mortality

Outcome Measures

Primary Outcomes (1)

  • delays to treatment

    Quantification of hospital attributable effects relating to early and late mortality

    12 months

Secondary Outcomes (1)

  • Describing trajectories of quality of life recovery patterns

    12 month

Other Outcomes (1)

  • Develop a risk score and a near-point risk Acute Coronary Syndrome model

    two years

Study Arms (1)

Acute myocardial infarction

patient with suspected acute coronary syndrome (ACS).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients at a terminal stage of any illness
  • Those in whom follow up would be inappropriate or impractical

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (6)

  • Munyombwe T, Dondo TB, Hall M, Nadarajah R, Hurdus B, Aktaa S, Haris M, Keeley A, West R, Hall A, Norman P, Gale CP. Cohort profile: Evaluation of the Methods and Management of Acute Coronary Events (EMMACE) Longitudinal Cohort. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):442-446. doi: 10.1093/ehjqcco/qcad040.

    PMID: 37451698DERIVED

  • 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.

    PMID: 36351712DERIVED

  • 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.

    PMID: 34579718DERIVED

  • 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.

    PMID: 32826289DERIVED

  • 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.

    PMID: 31699696DERIVED

  • 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.

    PMID: 26105029DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

  • Chris P Gale, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 8, 2013

Study Start

February 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

GB(1)