NCT01704300

Brief Summary

The association between obesity and cardiovascular disease (CVD) has mostly been studied using broad endpoints or have focused on cause-specific mortality. The investigators aim to compare the effect of body mass index (BMI) on different types of initial presentation of CVD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,240,000

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
completed

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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

9.2 years

First QC Date

October 8, 2012

Last Update Submit

October 10, 2012

Conditions

Keywords

Abdominal aortic aneurysmAcute Myocardial InfarctionCoronary heart disease not otherwise specifiedHaemorrhagic strokeHeart failureIschaemic strokePeripheral arterial diseaseStable anginaUnheralded coronary deathUnstable anginaVentricular arrhythmias, cardiac arrest and sudden cardiac deathTransient Ischemic Attack

Study Arms (1)

CALIBER Healthy Cohort

We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database \[GPRD\]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS).

Eligibility Criteria

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

The cohort we will use in the present analysis has been drawn from patients across 225 practices in England contributing data to GPRD, covering approximately 5% of the UK population (Figure 1). The study period is 1st January 2001 to 25th March 2010 (the date of the last GPRD data submission). To allow time for medical history and risk factors to be measured and recorded we require that patients enter the cohort after having completed at least 1 year of registration with their current practice during which the practice provides data that meet research quality criteria. Patients are followed up from the date they become eligible to be included in the cohort until the earliest date among a) the date of an initial presentation with one of the endpoints of interest, b) the date of leaving the practice or c) the date of last data submission from their practice.

You may qualify if:

  • Baseline age ≥30 years

You may not qualify if:

  • prior atherosclerotic disease or stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalStrokeHeart FailurePeripheral Arterial DiseaseAngina PectorisHemorrhagic StrokeIschemic StrokeAngina, StableAngina, UnstableHeart ArrestDeath, Sudden, CardiacIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesMyocardial IschemiaChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDeath, SuddenDeathPathologic ProcessesBrain Ischemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Harry Hemingway, FRCP

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

January 1, 2001

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations