NCT02062021

Brief Summary

Autoimmune diseases are diseases in which inappropriate immune responses that have the capability of harming host cells play an important role. Evidence suggests that the presence of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus erythematosus increase the risk of cardiovascular disease (CVD). However, this evidence is inconsistent for autoimmune disorders and no systematic approach has been previously used to study the relationship between a range of common autoimmune disorders and specific forms of cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid haemorrhage, or venous thrombosis. The investigators will use linked electronic health records to investigate whether commonly diagnosed autoimmune disorders are associated with increased risk of CVD development and whether effects differ in men and women and change with age.

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
200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

January 30, 2014

Last Update Submit

April 20, 2015

Conditions

Myocardial InfarctionIschemic StrokeStrokeSubarachnoid HaemorrhageVenous ThrombosisTransient Ischemic AttackStable Angina PectorisUnstable AnginaHeart FailurePeripheral Arterial DiseaseAbdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (3)

  • Rate ratios for the associations between presence of autoimmune disorders and initial presentation of myocardial infarction

    Associated studies: overall, by sex, by age group

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke

    Associated studies: overall, by sex, by age group

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • Rate ratios for the associations between presence of autoimmune disorders and initial presentation of stroke and venous thrombosis

    Associated studies: overall, by sex, by age group

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

Secondary Outcomes (6)

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of stable angina

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of unstable angina

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of heart failure

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of peripheral arterial disease

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • Hazard ratios for the association between the presence of autoimmune disease and the initial presentation of transient ischemic attack

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Cumulative incidence per autoimmune disease status

    Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 5 years)

Interventions

No interventionOTHER

Eligibility Criteria

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

Patients registered in Clinical Practice Research Datalink (CPRD) practices

You may qualify if:

  • One year prior to study entry
  • years or older
  • Recorded sex
  • Free of symptomatic cardiovascular disease at entry

You may not qualify if:

  • Prior cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, United Kingdom

Location

MeSH Terms

Conditions

Myocardial InfarctionIschemic StrokeStrokeSubarachnoid HemorrhageVenous ThrombosisIschemic Attack, TransientAngina, StableAngina, UnstableHeart FailurePeripheral Arterial DiseaseAortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial HemorrhagesHemorrhageThrombosisEmbolism and ThrombosisBrain IschemiaAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesAortic AneurysmAneurysmAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology and Public Health

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 13, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

GB(1)