Acute Myocardial InfarctionNCT02786654
β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure
An observational study of Acute Myocardial Infarction, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 179,810 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Jun 2013
- How long will I take part?
- 6 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprised of 179,810 in hospital survivors of acute myocardial infarction without heart failure recorded in the Myocardial Ischaemia National Audit Project registry between 2007 and June 2013
Who may be able to join
- acute myocardial infarction patients only
- aged 18 to 100 years
Who cannot join
- other final diagnosis besides acute myocardial infarction
- died in-hospital
- patients with missing mortality data
- aged > 100
- patients with previous acute myocardial infarction or angina
- patients who have received coronary interventions before
Show all 10Show fewer
- patients with heart failure
- patients with β blocker prior use
- patients contraindicated for β blocker use
- patients with use of a loop diuretic
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, mortality, evidence-based care, Myocardial Ischaemia National Audit Project, β blockers
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 1 year
Secondary outcomes (2)
All cause mortality
Measured: 6 months
All cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJan 2007
- Primary completionJun 2013
- Study completionJun 2013
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
- 179,810 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatendashe Bernadette Dondo, University of Leeds
- Investigators
- Chris P Gale, FRCP, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786654
- Sponsor's protocol ID
- PG/13/81/30474BB
- Status last verified
- Jun 2019
- First submitted
- 26 May 2016
- Last updated
- 18 Jun 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Dondo TB, Hall M, West RM, Jernberg T, Lindahl B, Bueno H, Danchin N, Deanfield JE, Hemingway H, Fox KAA, Timmis AD, Gale CP. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction. J Am Coll Cardiol. 2017 Jun 6;69(22):2710-2720. doi: 10.1016/j.jacc.2017.03.578.
PubMed 28571635
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure
- ClinicalTrials.gov ID
- NCT02786654
- Acronym / sponsor ID
- PG/13/81/30474BB
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, mortality, evidence-based care, Myocardial Ischaemia National Audit Project, β blockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179,810 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Jun 2016 (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.
The aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised of 179,810 in hospital survivors of acute myocardial infarction without heart failure recorded in the Myocardial Ischaemia National Audit Project registry between 2007 and June 2013
Key inclusion criteria (2 listed)
- acute myocardial infarction patients only
- aged 18 to 100 years
Key exclusion criteria (10 listed)
- other final diagnosis besides acute myocardial infarction
- died in-hospital
- patients with missing mortality data
- aged > 100
- patients with previous acute myocardial infarction or angina
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
All cause mortality
Time frame: 1 year
2 secondary outcomes
All cause mortality
Time frame: 6 months
All cause mortality
Time frame: 30 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 18 Jun 2019.
- Background: PubMed 28571635Dondo TB, Hall M, West RM, Jernberg T, Lindahl B, Bueno H, Danchin N, Deanfield JE, Hemingway H, Fox KAA, Timmis AD, Gale CP. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction. J Am Coll Cardiol. 2017 Jun 6;69(22):2710-2720. doi: 10.1016/j.jacc.2017.03.578.
- 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 P Gale, FRCP 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 Acute Myocardial Infarction, 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 2 inclusion and 10 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 18 Jun 2019. 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?
All cause mortality (time frame: 1 year). 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 NCT02786654, 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 18 Jun 2019.