Acute Coronary SyndromeEMMACE-3XNCT01955525
Long-term Follow-up of Health Related Quality of Life in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible associations with their cardiovascular profile and to ii) Linkage these data to multiple electronic healthcare records Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 3,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Nov 2023
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been hospitalised with an ACS during the period of 2011 to 2013 and took part in EMMACE3 study(REC number 10/H1313/74)
Who may be able to join
- Age>=18 years, both sexes, acute admission to hospital in England with an ACS, consented to participate in EMMACE3 study
Who cannot join
- Those in whom follow up would be inappropriate or impractical (for example patients in the terminal stages of an illness or requiring emergency treatment such that the gathering research data is not possible or appropriate.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
Oras A Alabas, BSC, MSC, PhD, +44113 343 ext. 8874, o.alabas@leeds.ac.uk
Chris P Gale, BSc MBBS MRCP Ph.D M.Ed FESC
About this study
Official title: Long-term Follow-up of Health Related Quality of Life in Patients Hospitalised With Acute Coronary Syndrome: Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-3X
This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible associations with their cardiovascular profile and to ii) Linkage these data to multiple electronic healthcare records
Read the 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 health quality of life.
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'. This research is a long term followup that promote improved patient care. In doing so, different factors affecting cardiac rehabilitation will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, health related quality of life, mortality
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute coronary patients | Patients aged 18 and above who have been hospitalised with an ACS during the period of 2011 to 2013. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
This research will therefore allow greater insights into the associations of patients and hospital characteristics with longerterm outcomes after ACS. It will identify good hospital practice and make recommendations for hospital care that will improve patient wellbeing.
Measured: 10 years
Secondary outcomes (1)
Mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 3,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oras Alabas, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955525
- Sponsor's protocol ID
- IRAS ID: 134080
- Acronym
- EMMACE-3X
- Status last verified
- Sep 2013
- First submitted
- 28 Sep 2013
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Health Related Quality of Life in Patients Hospitalised With Acute Coronary Syndrome: Evaluation of the Methods and Management of Acute Coronary Events (EMMACE)-3X
- ClinicalTrials.gov ID
- NCT01955525
- Acronym / sponsor ID
- EMMACE-3X / IRAS ID: 134080
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, health related quality of life, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 7 Oct 2013 (estimated)
- 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.
This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible associations with their cardiovascular profile and to ii) Linkage these data to multiple electronic healthcare records
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 health quality of life.
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'. This research is a long term followup that promote improved patient care. In doing so, different factors affecting cardiac rehabilitation will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute coronary patients | – | –Patients aged 18 and above who have been hospitalised with an ACS during the period of 2011 to 2013. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been hospitalised with an ACS during the period of 2011 to 2013 and took part in EMMACE3 study(REC number 10/H1313/74)
Key inclusion criteria (1 listed)
- Age>=18 years, both sexes, acute admission to hospital in England with an ACS, consented to participate in EMMACE3 study
Key exclusion criteria (1 listed)
- Those in whom follow up would be inappropriate or impractical (for example patients in the terminal stages of an illness or requiring emergency treatment such that the gathering research data is not possible or appropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health related quality of life
Time frame: 10 years
This research will therefore allow greater insights into the associations of patients and hospital characteristics with longerterm outcomes after ACS. It will identify good hospital practice and make recommendations for hospital care that will improve patient wellbeing.
1 secondary outcome
Mortality
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
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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.
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 Acute Coronary Syndrome, 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 1 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: status not confirmed, as of the sponsor's last update on 7 Oct 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris P Gale, BSc MBBS MRCP Ph.D M.Ed FESC (+44113 343 ext. 8916, c.p.gale@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2013.