Acute Myocardial InfarctionNCT03037255
Association of Long-term Conditions With Survival Following Heart Attack in England and Wales
An observational study of Acute Myocardial Infarction and Diabetes Mellitus, run by Marlous Hall.
Trial summary
This study aims to determine the extent to which pre-existing long-term conditions are associated with survival following a heart attack (acute myocardial infarction) using observational data from the UK's national heart attack register. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Diabetes Mellitus, Peripheral Vascular Disease
- What is being tested?
- long term conditions
- How many people
- 693,633 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jan 2021
- How long will I take part?
- 8 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 with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) admitted to one of 247 hospitals in England and Wales between 1st January 2003 and 30th June 2013
Who may be able to join
- Patients must be 18 years or older
Who cannot join
- Patients for which mortality data are missing
About this study
Official title: Association of Long-term Conditions With Survival Following Acute Myocardial Infarction in England and Wales
This study aims to determine the extent to which pre-existing long-term conditions are associated with survival following a heart attack (acute myocardial infarction) using observational data from the UK's national heart attack register.
Read the detailed description
Using observational data from the Myocardial Ischaemia National Audit Project (MINAP) of all hospitalisations for acute myocardial infarction in all acute hospitals in England and Wales, this study aims to determine the extent to which pre-existing long-term conditions are associated with survival following acute myocardial infarction. The study will include an investigation of individual long term conditions for patients with acute myocardial infarction, including chronic heart failure, cerebrovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, chronic renal failure or peripheral vascular disease as well as the combination of such conditions and their resulting impact on long term all-cause mortality (up to 8.4 years). In addition, an investigation of the association of receipt of guideline recommended care for acute myocardial infarction patients with pre-existing long term conditions will be made.
- Conditions
- Acute Myocardial Infarction, Diabetes Mellitus, Peripheral Vascular Disease, Chronic Heart Failure, Cerebrovascular Disease, Chronic Renal Failure
- Being tested
- long term conditions
- Medical subject headings
- Diabetes Mellitus, Peripheral Vascular Diseases, Cerebrovascular Disorders, Kidney Failure, Chronic, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long term conditionsOther
Long term conditions including diabetes mellitus, chronic obstructive pulmonary disease or asthma, chronic heart failure, chronic renal failure, cerebrovascular disease or peripheral vascular disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who died from any cause by the end of the study censoring period
Death data was obtained from national death records from the Office for National Statistics
Measured: 8.4 years
Secondary outcomes (1)
Number of patients who received guideline recommended therapy during the study period
All guideline recommended therapies for acute myocardial infarction relevant to the duration of the study period (2003 to 2013) will be assessed.
Measured: Any guideline therapy administered during the patients hospital admission for acute myocardial infarction, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJan 2003
- Primary completionDec 2013
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- 693,633 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Marlous Hall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marlous Hall, University of Leeds
- Investigators
- Chris Gale, PhD, FRCP, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037255
- Sponsor's protocol ID
- UoL_LTC
- Status last verified
- May 2022
- First submitted
- 24 Jan 2017
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hall M, Dondo TB, Yan AT, Mamas MA, Timmis AD, Deanfield JE, Jernberg T, Hemingway H, Fox KAA, Gale CP. Multimorbidity and survival for patients with acute myocardial infarction in England and Wales: Latent class analysis of a nationwide population-based cohort. PLoS Med. 2018 Mar 6;15(3):e1002501. doi: 10.1371/journal.pmed.1002501. eCollection 2018 Mar.
PubMed 29509764
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Long-term Conditions With Survival Following Acute Myocardial Infarction in England and Wales
- ClinicalTrials.gov ID
- NCT03037255
- Acronym / sponsor ID
- UoL_LTC
- Conditions
- Acute Myocardial Infarction, Diabetes Mellitus, Peripheral Vascular Disease, Chronic Heart Failure, Cerebrovascular Disease, Chronic Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 693,633 participants (actual)
- Lead sponsor
- Marlous HallUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 31 Jan 2017 (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 aims to determine the extent to which pre-existing long-term conditions are associated with survival following a heart attack (acute myocardial infarction) using observational data from the UK's national heart attack register.
Detailed description
Using observational data from the Myocardial Ischaemia National Audit Project (MINAP) of all hospitalisations for acute myocardial infarction in all acute hospitals in England and Wales, this study aims to determine the extent to which pre-existing long-term conditions are associated with survival following acute myocardial infarction. The study will include an investigation of individual long term conditions for patients with acute myocardial infarction, including chronic heart failure, cerebrovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, chronic renal failure or peripheral vascular disease as well as the combination of such conditions and their resulting impact on long term all-cause mortality (up to 8.4 years). In addition, an investigation of the association of receipt of guideline recommended care for acute myocardial infarction patients with pre-existing long term conditions will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) admitted to one of 247 hospitals in England and Wales between 1st January 2003 and 30th June 2013
Key inclusion criteria (1 listed)
- Patients must be 18 years or older
Key exclusion criteria (1 listed)
- Patients for which mortality data are missing
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 |
|---|---|---|
| long term conditionsLong term conditions including diabetes mellitus, chronic obstructive pulmonary disease or asthma, chronic heart failure, chronic renal failure, cerebrovascular disease or peripheral vascular disease. | Other | – |
Primary outcome
Number of patients who died from any cause by the end of the study censoring period
Time frame: 8.4 years
Death data was obtained from national death records from the Office for National Statistics
1 secondary outcome
Number of patients who received guideline recommended therapy during the study period
Time frame: Any guideline therapy administered during the patients hospital admission for acute myocardial infarction, an average of 4 days
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 24 May 2022.
- Derived from this study: PubMed 29509764Hall M, Dondo TB, Yan AT, Mamas MA, Timmis AD, Deanfield JE, Jernberg T, Hemingway H, Fox KAA, Gale CP. Multimorbidity and survival for patients with acute myocardial infarction in England and Wales: Latent class analysis of a nationwide population-based cohort. PLoS Med. 2018 Mar 6;15(3):e1002501. doi: 10.1371/journal.pmed.1002501. eCollection 2018 Mar.
- Principal Researchers Profile PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Gale, PhD, FRCP principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Diabetes Mellitus, run by Marlous Hall.
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: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients who died from any cause by the end of the study censoring period (time frame: 8.4 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 NCT03037255, which also lists 1 linked publication.
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 24 May 2022.