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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02261324
Other study ID # 2013LF001H
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2013
Est. completion date January 2021

Study information

Verified date March 2021
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 560
Est. completion date January 2021
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United Kingdom Harefield Hospital Harefield Middlesex

Sponsors (2)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality rate 1 year
Secondary Occurrence of cardiovascular events 1 and 5 years
Secondary Need for repeat revascularisation 1 and 5 years
Secondary Health resource usage 1 and 5 years
Secondary All-cause mortality 5 years
Secondary Cardiovascular death 1 and 5 years
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