β Blocker Use and Mortality in Hospital Survivors of Acut... | NCT02786654

Studies
β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure

NCT02786654

Sponsor

University of Leeds

Status

Completed

Last Update Posted

Jun 18, 2019Actual

Enrollment

179,810Actual

Phase

Not provided

Conditions

Acute 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 2007

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 26, 2016

First Submission Date that Met QC Criteria

May 26, 2016

First Posted Date

Jun 1, 2016Estimated

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

Description Module

Brief 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.

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

6 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

179,810Actual

Measure	Description	Time Frame
All cause mortality		1 year

Measure	Description	Time Frame
All cause mortality		6 months
All cause mortality		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute myocardial infarction patients only
aged 18 to 100 years

Exclusion Criteria:

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
patients with heart failure
patients with β blocker prior use
patients contraindicated for β blocker use
patients with use of a loop diuretic

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 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris P Gale, FRCP	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
28571635	Background	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.