NCT01947361

Brief Summary

Study of heterogeneity in associations between heart rate 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
1,961,286

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
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
2 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 20, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

September 12, 2013

Last Update Submit

September 17, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Risk of atherosclerotic disease in patients with high or low heart rate

    Hazard ratios will be also presenting associations between heart rate and initial presentation of different cardiovascular diseases. These associations will be also measured between different levels of heart rate and CVDs stratified by: * by sex * gender * a range of risk factors (such as physical activity, smoking status, drinking status, etc.)

    Participants were followed until the first Coronary disease event (an expected average of 5 years)

Secondary Outcomes (1)

  • Incidence proportions and life time risk for Cardiovascular diseases

    Participants were followed until the first Coronary disease event (an expected average of 5 years)

Eligibility Criteria

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

1,96 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).
  • \> 30 years old
  • have at least a recorded heart rate measurement during the study period

You may not qualify if:

  • \- Evidence of prior atherosclerotic or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 7H, United Kingdom

Location

Related Publications (1)

  • Archangelidi O, Pujades-Rodriguez M, Timmis A, Jouven X, Denaxas S, Hemingway H. Clinically recorded heart rate and incidence of 12 coronary, cardiac, cerebrovascular and peripheral arterial diseases in 233,970 men and women: A linked electronic health record study. Eur J Prev Cardiol. 2018 Sep;25(14):1485-1495. doi: 10.1177/2047487318785228. Epub 2018 Jul 2.

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

September 12, 2013

First Posted

September 20, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations