Is the 4MGS a Useful Outcome Measure Post-PPCI | NCT02261324

Studies
Is the 4MGS a Useful Outcome Measure Post-PPCI

NCT02261324

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Status

Completed

Last Update Posted

Mar 12, 2021Actual

Enrollment

560Actual

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

Mar 2021

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

Dec 2013

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2021Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

Oct 9, 2014

First Posted Date

Oct 10, 2014Estimated

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

Mar 10, 2021

Last Update Posted Date

Mar 12, 2021Actual

Name	Class
Medical Research Council	OTHER_GOV

Description Module

Brief Summary

This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to assess whether this can predict future cardiovascular events and death.

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

560Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of cardiovascular events		1 and 5 years
Need for repeat revascularisation		1 and 5 years
Health resource usage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient hospitalised with an acute myocardial infarction who has undergone primary percutaneous coronary intervention
Capacity to consent
Able to walk
Age over 18 years

Exclusion Criteria:

Significant co-morbidities that would limit exercise capacity or make exercise unsafe (e.g. neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)

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

Any patient hospitalised for primary percutaneous coronary intervention for acute myocardial infarction. The cohort will be recruited from Harefield hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William DC Man, FRCP PhD	NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harefield Hospital		Harefield	Middlesex	UB9 6JH	United Kingdom