Guideline Recommended Care and Excess Mortality for Non S... | NCT02436187

Studies
Guideline Recommended Care and Excess Mortality for Non ST-elevation Myocardial Infarction : A National Cohort Study

NCT02436187

Sponsor

University of Leeds

Status

Completed

Last Update Posted

Jun 18, 2019Actual

Enrollment

389,057Actual

Phase

Not provided

Conditions

Non ST-elevation Myocardial Infarction

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Mar 30, 2015

First Submission Date that Met QC Criteria

May 1, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2019

Last Update Posted Date

Jun 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to quantify the excess mortality associated with non-adherence to care for non ST-elevation myocardial infarction in England and Wales over the last decade.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

389,057Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		Participants will be followed up for an expected average of 8 years 6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of missed guideline recommended care opportunities		Participants will be followed up for an expected average of 8 years 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18 years or more
patients hospitalised with non ST-elevation myocardial infarction

Exclusion Criteria:

patients hospitalised with phenotypes other than non ST-elevation myocardial infarction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population comprised of 389,052 patients with non ST-elevation myocardial infarction admitted to hospital and were entered into Myocardial Ischaemia National Audit Project database between January 2003 and December 2013.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher P Gale, PhD	University of Leeds	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leeds		Leeds		LS2 9JT	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27142174	Background	Dondo TB, Hall M, Timmis AD, Gilthorpe MS, Alabas OA, Batin PD, Deanfield JE, Hemingway H, Gale CP. Excess mortality and guideline-indicated care following non-ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2017 Aug;6(5):412-420. doi: 10.1177/2048872616647705. Epub 2016 May 3.
27406646	Background

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases