Cardiovascular DiseasesEMMACE-XLNCT04598048
Quality of Life Post-ACS in Participants from EMMACE
An observational study of Cardiovascular Diseases, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2020to 8 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Surviving participants of the EMMACE 3 \& 4 studies, who have agreed to be contacted for further research
Who cannot join
- Concerns by the research team of mental capacity.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
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.
Read the detailed description
Health-related quality of life (HRQoL) after myocardial infarction (MI) is an important clinical outcome. It allows the definition of health outcomes from a patient's perspective and, therefore, offers the potential to collect patient-centered ill-health, which may be used as an additional endpoint in the evaluation of care. Many survivors of MI experience poor HRQoL, and many patients consider the quality of additional life years gained just as important as the length of life. The goal of contemporary therapies, therefore, should be not only to extend life expectancy, but also to ensure a high quality long-term health state. Accordingly, HRQoL is increasingly being used as an outcome measure in clinical trials evaluating both the impact of disease burden and the effectiveness of cardiovascular interventions.
Research has shown that changes in HRQoL are associated with a range of clinical outcomes, including death, anxiety and depression, and medications compliance. Changes in HRQoL have been reported to negatively impact healthcare costs, and employment. However, there is a paucity of information about the relationship between HRQoL and clinical outcomes inherent following MI. Moreover, previous research is limited by small sample sizes, poor generalisability,selection bias, the use of retrospective cross-sectional designs,and short follow-up durations of 6 months - 2 years. For example in our previous studies (EMMACE 3 and 4 ), we followed up patients for up to 2 years. The EMMACE data analysis showed that over two years HRQoL improved for the majority (two thirds) but was significantly worse and more likely to decline for women, NSTEMI, and people with long-term health conditions .
Whilst the analysis of EMMACE demonstrates promising results, the EMMACE data are limited by the short follow up period of up to 2 years. We have been funded by the British Heart Foundation (Program grant number PG/19/54/34511) to link the EMMACE 3 and 4 data to ONS (mortality) and Hospital Episode Statistics (HES) data such that longer-term non-fatal and fatal outcomes and healthcare utilisation may be studied. All patients were consented to enter the EMMACE 3 and 4 studies and for their self-reported data to be linked to future electronic health record data. EMMACE data has already been successfully linked to data from the national heart attack registry (Myocardial Ischemia National Audit project, MINAP) thus providing information about hospital treatment for MI and comorbidities. This study will provide a further follow up of this data so that longer term follow up can be studied.
To complement our work, and given the paucity on longer term HRQoL data, in this proposal we aim to collect > 5 years HRQoL measures data from the participants of EMMACE 3 \& 4 studies. The longer follow up of HRQoL data (> 5 years) may provide insights into understanding the association between long term changes in HRQoL and subsequent clinical outcomes and precisely in whom worse (or better) outcomes may occur will permit the design and testing of novel intervention to reduce premature death from MI.
The planned research will provide unique and comprehensive insight into the relationship between changes in HRQoL and survival following MI. Health-related quality of life is a patient reported outcome measure (PROM) which can detect change in risk of events for patients, and potentially serve as a predictor of future risk (using patient-facing data capture tools). Understanding the association between changes in HRQoL and health outcomes and precisely in whom worse (or better) outcomes may occur will permit the design and testing of novel interventions to reduce premature death from MI.
- Conditions
- Cardiovascular Diseases
- Being tested
- Questionnaire
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Patients will complete an EQ-5D questionnaire, medication and lifestyle questions
| Study group | Role | What they receive |
|---|---|---|
| EMMACE 3 | Participants who were recruited to the EMMACE 3 study and have agreed to contact for further research. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first recruited into data received - approx 10 years
Secondary outcomes (3)
To investigate the association between changes in HRQoL and mortality post ACS.
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. The data will also be linked to mortality data supplied by ONS. Sequential EQ-5D-3L and EQVAS data will be used both as a measure of outcome (recovery pattern) and predictor of outcome. Joint modelling of changes in HRQoL and survival will be used to investigate the association of HRQoL and mortality.
Measured: 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.
We will use mortality and hospital episodes data for all patients recruited to the EMMACE 3 and 4 studies to compare their fatal and non fatal health outcomes to see if there are any common patient clusters with respect to these outcomes.
Measured: 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
We will combine mortality, hospital episodes data, EQ-5D and medication adherence responses from surviving ACS patients for the EMMACE 3 and 4 studies who have consent to further follow up to investigate whether there is any associations between quality of care, cardiac rehabilitation, medications, patient characteristics, socioeconomic status, changes in HRQoL with mortality.
Measured: From first recruited into data received - approx 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start27 Sep 2020
- Primary completion31 Mar 2021
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Christopher Gale, University of Leeds
- Investigators
- Chris P Gale, Prof, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598048
- Sponsor's protocol ID
- 20/PR/0104
- Other IDs
- 276202, PG/19/54/34511
- Acronym
- EMMACE-XL
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared as per patient consent.
Publications
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.
PubMed 26105029Munyombwe 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.
PubMed 31699696Dondo 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.
PubMed 36351712
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Post-ACS in Participants from EMMACE
- ClinicalTrials.gov ID
- NCT04598048
- Acronym / sponsor ID
- EMMACE-XL / 20/PR/0104
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,400 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Health-related quality of life (HRQoL) after myocardial infarction (MI) is an important clinical outcome. It allows the definition of health outcomes from a patient's perspective and, therefore, offers the potential to collect patient-centered ill-health, which may be used as an additional endpoint in the evaluation of care. Many survivors of MI experience poor HRQoL, and many patients consider the quality of additional life years gained just as important as the length of life. The goal of contemporary therapies, therefore, should be not only to extend life expectancy, but also to ensure a high quality long-term health state. Accordingly, HRQoL is increasingly being used as an outcome measure in clinical trials evaluating both the impact of disease burden and the effectiveness of cardiovascular interventions.
Research has shown that changes in HRQoL are associated with a range of clinical outcomes, including death, anxiety and depression, and medications compliance. Changes in HRQoL have been reported to negatively impact healthcare costs, and employment. However, there is a paucity of information about the relationship between HRQoL and clinical outcomes inherent following MI. Moreover, previous research is limited by small sample sizes, poor generalisability,selection bias, the use of retrospective cross-sectional designs,and short follow-up durations of 6 months - 2 years. For example in our previous studies (EMMACE 3 and 4 ), we followed up patients for up to 2 years. The EMMACE data analysis showed that over two years HRQoL improved for the majority (two thirds) but was significantly worse and more likely to decline for women, NSTEMI, and people with long-term health conditions .
Whilst the analysis of EMMACE demonstrates promising results, the EMMACE data are limited by the short follow up period of up to 2 years. We have been funded by the British Heart Foundation (Program grant number PG/19/54/34511) to link the EMMACE 3 and 4 data to ONS (mortality) and Hospital Episode Statistics (HES) data such that longer-term non-fatal and fatal outcomes and healthcare utilisation may be studied. All patients were consented to enter the EMMACE 3 and 4 studies and for their self-reported data to be linked to future electronic health record data. EMMACE data has already been successfully linked to data from the national heart attack registry (Myocardial Ischemia National Audit project, MINAP) thus providing information about hospital treatment for MI and comorbidities. This study will provide a further follow up of this data so that longer term follow up can be studied.
To complement our work, and given the paucity on longer term HRQoL data, in this proposal we aim to collect > 5 years HRQoL measures data from the participants of EMMACE 3 \& 4 studies. The longer follow up of HRQoL data (> 5 years) may provide insights into understanding the association between long term changes in HRQoL and subsequent clinical outcomes and precisely in whom worse (or better) outcomes may occur will permit the design and testing of novel intervention to reduce premature death from MI.
The planned research will provide unique and comprehensive insight into the relationship between changes in HRQoL and survival following MI. Health-related quality of life is a patient reported outcome measure (PROM) which can detect change in risk of events for patients, and potentially serve as a predictor of future risk (using patient-facing data capture tools). Understanding the association between changes in HRQoL and health outcomes and precisely in whom worse (or better) outcomes may occur will permit the design and testing of novel interventions to reduce premature death from MI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMMACE 3 | – | Behavioral: QuestionnaireParticipants who were recruited to the EMMACE 3 study and have agreed to contact for further research. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Surviving participants of the EMMACE 3 \& 4 studies, who have agreed to be contacted for further research
Key exclusion criteria (2 listed)
- Concerns by the research team of mental capacity.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients will complete an EQ-5D questionnaire, medication and lifestyle questions | Behavioural | EMMACE 3 |
Primary outcome
To describe ACS patients according to their changes in HRQoL trajectory and determine factors associated with poor HRQoL.
Time frame: From first recruited into data received - approx 10 years
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.
3 secondary outcomes
To investigate the association between changes in HRQoL and mortality post ACS.
Time frame: 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.
Time frame: 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
Time frame: From first recruited into data received - approx 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 26105029Alabas 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.
- Background: PubMed 31699696Munyombwe 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.
- Derived from this study: PubMed 36351712Dondo 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared as per patient consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris P Gale, Prof principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe ACS patients according to their changes in HRQoL trajectory and determine factors associated with poor HRQoL. (time frame: From first recruited into data received - approx 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598048, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.