Non ST-elevation Myocardial InfarctionNCT02693015
Impact of Time to Coronary Angiography on Survival for NSTEMI
An observational study of Non ST-elevation Myocardial Infarction, run by University of Leeds.
Trial summary
This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non ST-elevation Myocardial Infarction
- How many people
- 235,986 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Mar 2013
- How long will I take part?
- 1 Year
- 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 comprises 725,860 patients hospitalised for acute myocardial infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP) database between April 2004 and March 2013.
Who may be able to join
- The target population will be all patients aged 18 to 100 years recorded within MINAP from 2004 to 2013 who have been hospitalised with NSTEMI and received coronary angiography.
Who cannot join
- Age below 18 or above 100 or age missing
- Diagnosis not NSTEMI
- Patients who did not receive coronary angiography - as this is the investigators explanatory variable
About this study
Official title: Impact of Time to Coronary Angiography on Survival for NSTEMI: an Observation Study Using a Nationwide Registry
This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI.
Read the detailed description
The use of an invasive strategy for the management of NSTEMI according to estimated risk of 6 month mortality is recommended by international guidelines. NSTEMI appropriate for coronary angiography (and percutaneous intervention) have better outcomes compare with NSTEMI who are medically managed. Whilst the national and international guidelines recommend that the timing of (in-hospital) coronary angiography (<24, 24-72, 72-96 and <96 hours) is based upon estimated clinical risk (using the GRACE risk score) there is scientific and clinical uncertainty as to the incremental benefit that more urgent invasive treatments strategies have over and above that of delayed strategies. Moreover, the investigators recent research has shown that in the UK, may NSTEMI (eligible) for coronary angiography fail to achieve care according to the recommended time thresholds, and this is associated with potentially avoidable premature death.
This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI. It will characterise patients according to their estimated risk of death, their time to angiography, and associated outcomes. The investigators anticipate that this observational study will provide Level B evidence for the benefits of the timing of an invasive strategy according to the GRACE risk score. The investigators are aware that the NICE guidelines for the management of acute chest pain are to be updated in 2016.
- Conditions
- Non ST-elevation Myocardial Infarction
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30-day mortality since hospitalisation
Mortality
Measured: 1-year mortality since hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2004
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST-elevation 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
- 235,986 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Christopher Gale, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693015
- Sponsor's protocol ID
- Time to coronary angiography
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time to Coronary Angiography on Survival for NSTEMI: an Observation Study Using a Nationwide Registry
- ClinicalTrials.gov ID
- NCT02693015
- Acronym / sponsor ID
- Time to coronary angiography
- Conditions
- Non ST-elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235,986 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Feb 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.
This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI.
Detailed description
The use of an invasive strategy for the management of NSTEMI according to estimated risk of 6 month mortality is recommended by international guidelines. NSTEMI appropriate for coronary angiography (and percutaneous intervention) have better outcomes compare with NSTEMI who are medically managed. Whilst the national and international guidelines recommend that the timing of (in-hospital) coronary angiography (<24, 24-72, 72-96 and <96 hours) is based upon estimated clinical risk (using the GRACE risk score) there is scientific and clinical uncertainty as to the incremental benefit that more urgent invasive treatments strategies have over and above that of delayed strategies. Moreover, the investigators recent research has shown that in the UK, may NSTEMI (eligible) for coronary angiography fail to achieve care according to the recommended time thresholds, and this is associated with potentially avoidable premature death.
This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI. It will characterise patients according to their estimated risk of death, their time to angiography, and associated outcomes. The investigators anticipate that this observational study will provide Level B evidence for the benefits of the timing of an invasive strategy according to the GRACE risk score. The investigators are aware that the NICE guidelines for the management of acute chest pain are to be updated in 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises 725,860 patients hospitalised for acute myocardial infarction and entered into the Myocardial Ischaemia National Audit Project (MINAP) database between April 2004 and March 2013.
Key inclusion criteria (1 listed)
- The target population will be all patients aged 18 to 100 years recorded within MINAP from 2004 to 2013 who have been hospitalised with NSTEMI and received coronary angiography.
Key exclusion criteria (3 listed)
- Age below 18 or above 100 or age missing
- Diagnosis not NSTEMI
- Patients who did not receive coronary angiography - as this is the investigators explanatory variable
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: 30-day mortality since hospitalisation
Mortality
Time frame: 1-year mortality since hospitalisation
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 26 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non ST-elevation Myocardial Infarction, run by University of Leeds.
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 3 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 26 Feb 2016. 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?
All-cause mortality (time frame: 30-day mortality since hospitalisation). The study lists 2 primary outcomes in all. 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 26 Feb 2016.