NCT02261324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

May 1, 2014

Last Update Submit

March 10, 2021

Conditions

Acute Myocardial Infarction

Keywords

Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    1 year

Secondary Outcomes (5)

  • Occurrence of cardiovascular events

    1 and 5 years

  • Need for repeat revascularisation

    1 and 5 years

  • Health resource usage

    1 and 5 years

  • All-cause mortality

    5 years

  • Cardiovascular death

    1 and 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harefield Hospital

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Study Officials

  • William DC Man, FRCP PhD

    NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2014

First Posted

October 10, 2014

Study Start

December 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

GB(1)