NCT01687686

Brief Summary

The role of lipids as risk factors for cardiovascular events is well-documented, although events studied have largely been broad classes without specific detail. This study will examine a more refined set of endpoints.

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
175,872

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

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

Study Start

First participant enrolled

January 1, 2001

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

9.2 years

First QC Date

September 13, 2012

Last Update Submit

September 18, 2012

Conditions

Stable AnginaUnstable AnginaNon ST Elevation Myocardial InfarctionST Elevation Myocardial InfarctionMyocardial Infarction Not Otherwise Specified

Outcome Measures

Primary Outcomes (1)

  • Rate of stable angina

    Incidence of stable angina in study population

    Cohort followed up for average of 7 years

Secondary Outcomes (1)

  • Rate of unstable angina

    Cohort followed up for average of 7 years

Other Outcomes (1)

  • Rate of non ST elevation myocardial infarction

    Cohort followed up for average of 7 years

Study Arms (1)

All cohort

Initially healthy patients in General Practise Research Database (GPRD) meeting the inclusion criteria at any point between 1st January 2001 and 25th March 2010

Eligibility Criteria

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

The cohort used in the present analysis was drawn from patients registered with 225 GPRD general practices in England which consented to data linkage, covering approximately 5% of the UK population. We used an open cohort design, where participants joined the cohort when they met the inclusion criteria at any point between 1st January 2001 and 25th March 2010, the date of the last GPRD data submission. Patients were included in cohort if, prior to study entry, they were aged 30 to 100, had at least one year of electronic health record data which meet General Practice Research Database data quality standards, and had no record indicating any cardiovascular disease phenotypes. Patients were followed up until the date of an initial presentation of one of our cardiovascular endpoints or were censored on the date of leaving the practice or the date of last data submission from their practice.

You may qualify if:

  • Aged 30 to 100, had at least one year of electronic health record data which meet General Practice Research Database data quality standards

You may not qualify if:

  • No record indicating any cardiovascular disease phenotypes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, Greater London, WC1E 6BT, United Kingdom

Location

Related Publications (3)

  • Prospective Studies Collaboration; Lewington S, Whitlock G, Clarke R, Sherliker P, Emberson J, Halsey J, Qizilbash N, Peto R, Collins R. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet. 2007 Dec 1;370(9602):1829-39. doi: 10.1016/S0140-6736(07)61778-4.

    PMID: 18061058BACKGROUND

  • Emerging Risk Factors Collaboration; Di Angelantonio E, Sarwar N, Perry P, Kaptoge S, Ray KK, Thompson A, Wood AM, Lewington S, Sattar N, Packard CJ, Collins R, Thompson SG, Danesh J. Major lipids, apolipoproteins, and risk of vascular disease. JAMA. 2009 Nov 11;302(18):1993-2000. doi: 10.1001/jama.2009.1619.

    PMID: 19903920BACKGROUND

  • Ebrahim S, Sung J, Song YM, Ferrer RL, Lawlor DA, Davey Smith G. Serum cholesterol, haemorrhagic stroke, ischaemic stroke, and myocardial infarction: Korean national health system prospective cohort study. BMJ. 2006 Jul 1;333(7557):22. doi: 10.1136/bmj.38855.610324.80. Epub 2006 Jun 6.

    PMID: 16757495BACKGROUND

MeSH Terms

Conditions

Angina, StableAngina, UnstableNon-ST Elevated Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Medical Statistician

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 19, 2012

Study Start

January 1, 2001

Primary Completion

March 1, 2010

Study Completion

December 1, 2012

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

GB(1)