Impact of Initial Diagnosis on Mortality for Patients Hos... | NCT02600962

Studies
Impact of Initial Diagnosis on Mortality for Patients Hospitalised With Acute Myocardial Infarction

NCT02600962

Sponsor

University of Leeds

Status

Completed

Last Update Posted

Nov 9, 2015Estimated

Enrollment

564,412Actual

Phase

Not provided

Conditions

ST-elevation Myocardial Infarction
Non ST-elevation Myocardial Infarction

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
PG/13/81/30474	Other Grant/Funding Number	British Heart Foundation

Status Module

Record Verification Date

Nov 2015

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

Apr 2013Actual

Completion Date

Not provided

First Submitted Date

Nov 6, 2015

First Submission Date that Met QC Criteria

Nov 6, 2015

First Posted Date

Nov 9, 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

Nov 6, 2015

Last Update Posted Date

Nov 9, 2015Estimated

Name	Class
University College, London	OTHER

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 investigate the impact of an initial non-specific / non-cardiac diagnosis on mortality among patients hospitalised with acute myocardial infarction.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

564,412Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STEMI		Patients discharged with STEMI
NSTEMI		Patients discharged with NSTEMI

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality		Mortality censored 1 year after discharged from hospital

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged between 18 and 100 years
patients discharged alive with STEMI or NSTEMI

Exclusion Criteria:

patients who die in hospital
patients not discharged with STEMI or NSTEMI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction
D000072658	Non-ST Elevated Myocardial Infarction

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided