NCT01163513

Brief Summary

The purpose of this study is to determine the extent to which South Asian ethnicity is both an etiologic and prognostic factor for coronary disease, and investigate factors influencing outcomes.

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
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

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

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 21, 2011

Status Verified

July 1, 2010

Enrollment Period

4 months

First QC Date

April 16, 2010

Last Update Submit

February 18, 2011

Conditions

Keywords

ethnicityprognosis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    365 days Mortality from all causes from the date of admission

    365 days

Secondary Outcomes (1)

  • all causes in-hospital mortality

    length of hospital stay

Study Arms (5)

White population

Indian

Pakistani

Bangladeshi

Other

other South Asian

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ACS registry data (MINAP) - with hospital admission databases (Hospital Episode Statistics (HES)

You may qualify if:

  • An aetiological healthy population study, the Whitehall II Study, comprising non-industrial civil servants aged 35-55 years who worked in the London offices of 20 civil service departments at baseline (1985-1988), will be used
  • A chest pain clinic cohort of consecutive ambulatory patients with no prior investigations for coronary disease and no prior history of acute coronary syndrome recruited in six rapid access chest pain clinics from 1996-2002
  • A coronary angiography cohort of consecutive patients undergoing elective angiography at three centres in London between 1996-1997
  • Patients with a record in MINAP between 1 Jan 2003 - latest date available in 2009. Only index MINAP events will be included in the analysis.
  • We will exclude any study that covers an ethnic group other than South Asian, studies not on coronary disease and studies that examined cross-sectional mortality or cross-sectional associations of cardiovascular risk factors with populations.

You may not qualify if:

  • admitted to hospital with fewer than 25 admissions in given year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Epidemiology Group, Department of Epidemiology & Public Health, UCL

London, WC1E 6BT, United Kingdom

Location

Related Publications (1)

  • Zaman MJ, Philipson P, Chen R, Farag A, Shipley M, Marmot MG, Timmis AD, Hemingway H. South Asians and coronary disease: is there discordance between effects on incidence and prognosis? Heart. 2013 May;99(10):729-36. doi: 10.1136/heartjnl-2012-302925. Epub 2013 Feb 13.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2010

First Posted

July 15, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

February 21, 2011

Record last verified: 2010-07

Locations