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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02693015
Other study ID # Time to coronary angiography
Secondary ID
Status Completed
Phase N/A
First received February 23, 2016
Last updated February 25, 2016
Start date April 2004
Est. completion date March 2013

Study information

Verified date February 2016
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with NSTEMI.


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.


Recruitment information / eligibility

Status Completed
Enrollment 235986
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Leeds

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality 30-day mortality since hospitalisation No
Primary Mortality 1-year mortality since hospitalisation No
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