NCT01937065

Brief Summary

Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.

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
1,937,360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration 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, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

July 2, 2013

Last Update Submit

September 3, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hazard ratios for the associations between social deprivation and initial presentation of 12 cardiovascular diseases.

    Associations studied: * overall * by sex * by age group * in high risk groups (smokers, hypertensive disease, obese, diabetic, depression) * before and after the introduction of the Quality and Outcomes Framework in England

    Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years

Secondary Outcomes (1)

  • Lifetime cumulative incidence per quintile of social deprivation

    Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years

Other Outcomes (1)

  • Heterogeneity in associations across 12 cardiovascular diseases using the Tau-squared statistic and I-square statistics.

    Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years

Study Arms (1)

No treatment

Other: No treatment

Interventions

No treatment

Eligibility Criteria

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

1,93 million patients registered in Clinical Practice Research Datalink (CPRD) practices

You may qualify if:

  • One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
  • years or older
  • Recorded sex

You may not qualify if:

  • Pregnant women in the 6 months before the eligibility date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 7HN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalCerebral HemorrhageHeart FailureIschemic StrokeMyocardial InfarctionStrokePeripheral Arterial DiseaseAngina, StableSubarachnoid HemorrhageIschemic Attack, TransientAngina, UnstableHeart ArrestDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesMyocardial IschemiaInfarctionIschemiaNecrosisAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsBrain IschemiaDeath, SuddenDeath

Study Design

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

Study Record Dates

First Submitted

July 2, 2013

First Posted

September 9, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations