Quality of Life Post-ACS in Participants from EMMACE

NCT04598048 | Completed

• 3 other identifiers: 20/PR/0104276202PG/19/54/34511
• Study Type: observational
• Target: 13,400
• Locations: 1 country
• Sites: 1

Brief Summary

EMMACE-XL will recruit participants who are survivors of acute coronary syndrome (a type of heart attack) to assess their health-related quality of life five years or more after their heart attack. We will invite surviving participants from the EMMACE 3 and 4 studies to consent to participate in EMMACE-XL study, they will be asked to complete one questionnaire relating to their health, medication and lifestyle. The questionnaire will be linked to their data collected as part of the EMMACE 3 and 4 studies including long term follow up data from NHS Digital. The data collected from all the studies will then be analysed to see if patient groups can be identified who are at risk of poorer quality of life and worse health outcomes. These groups can then be targeted with the aim of improving their health outcomes. The study will use statistical methods to look at the relationship of factors such as; medication adherence, comorbidities and patient demographics on health-related quality of life and health outcomes.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• To describe ACS patients according to their changes in HRQoL trajectory and determine factors associated with poor HRQoL.

  Surviving ACS patients recruited in the EMMACE 3 and 4 studies and have consented to further contact will be contacted and requested to completed a EQ-5D questionnaire. Sequential EQ-5D-3L and EQVAS data will be used both as a measure of outcome (recovery pattern) and predictor of outcome. Multilevel modelling will be used to determine factors associated with poor HRQoL. The study will use statistical modelling approaches to investigate the relationship of factors such as; medication adherence, co-morbidities and patient demographics on health-related quality of life and health outcomes. This will help identify patient groups at risk of poorer quality of life and worse outcomes to enable these groups to be targeted to improve their outcomes.

  From first recruited into data received - approx 10 years

Secondary Outcomes (3)

• To investigate the association between changes in HRQoL and mortality post ACS.

  From first recruited into data received - approx 10 years

• To summarise the incidence of fatal and non-fatal health outcomes amongst our patients and determine if there are common patient clusters with respect to these outcomes.

  From first recruited into data received - approx 10 years

• To investigate the association of quality of care, cardiac rehabilitation, medications, patient characteristics, socioeconomic status, changes in HRQoL with mortality

  From first recruited into data received - approx 10 years

Study Arms (1)

EMMACE 3

Participants who were recruited to the EMMACE 3 study and have agreed to contact for further research.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Patients will complete an EQ-5D questionnaire, medication and lifestyle questions

EMMACE 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surviving participants of the EMMACE 3 \& 4 studies. Participants of the EMMACE 3 and 4 studies were recruited between November 2011 and June 2015 following a heart attack and admission to a UK hospital

You may qualify if:

• Surviving participants of the EMMACE 3 \& 4 studies, who have agreed to be contacted for further research

You may not qualify if:

• Concerns by the research team of mental capacity.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (3)

• 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: 26105029 BACKGROUND

• 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: 31699696 BACKGROUND

• 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: 36351712 DERIVED

Related Links

• Activities of the team and link to study information

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chris P Gale, Prof

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 22, 2020
• Study Start: September 27, 2020
• Primary Completion: March 31, 2021
• Study Completion: November 8, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)