Is the 4MGS a Useful Outcome Measure Post-PPCI

March 10, 2021 updated by: Royal Brompton & Harefield NHS Foundation Trust

Is the Four Metre Gait Speed a Useful Outcome Measure in Patients With Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention?

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Harefield Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 5 years
5 years
Occurrence of cardiovascular events
Time Frame: 1 and 5 years
1 and 5 years
Need for repeat revascularisation
Time Frame: 1 and 5 years
1 and 5 years
Health resource usage
Time Frame: 1 and 5 years
1 and 5 years
Cardiovascular death
Time Frame: 1 and 5 years
1 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Medical Research Council

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013LF001H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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