NCT01955525

Brief Summary

This study is aiming to i)measure longterm health related quality of life (HRQL) outcomes of the EMMACE3 patients hospitalised with acute coronary syndromes (ACS) and evaluate possible associations with their cardiovascular profile and to ii) Linkage these data to multiple electronic healthcare records

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 7, 2013

Status Verified

September 1, 2013

Enrollment Period

10 years

First QC Date

September 28, 2013

Last Update Submit

October 4, 2013

Conditions

Keywords

Acute coronary syndromehealth related quality of lifemortality

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    This research will therefore allow greater insights into the associations of patients and hospital characteristics with longerterm outcomes after ACS. It will identify good hospital practice and make recommendations for hospital care that will improve patient wellbeing.

    10 years

Secondary Outcomes (1)

  • Mortality

    10 years

Study Arms (1)

Acute coronary patients

Patients aged 18 and above who have been hospitalised with an ACS during the period of 2011 to 2013.

Eligibility Criteria

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

Patients who have been hospitalised with an ACS during the period of 2011 to 2013 and took part in EMMACE3 study(REC number 10/H1313/74)

You may qualify if:

  • Age\>=18 years, both sexes, acute admission to hospital in England with an ACS, consented to participate in EMMACE3 study

You may not qualify if:

  • Those in whom follow up would be inappropriate or impractical (for example patients in the terminal stages of an illness or requiring emergency treatment such that the gathering research data is not possible or appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Chris P Gale, BSc MBBS MRCP Ph.D M.Ed FESC

CONTACT

Oras A Alabas, BSc, MSc, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 28, 2013

First Posted

October 7, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

October 7, 2013

Record last verified: 2013-09

Locations