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An Observational Study of Natural History of Cardiovascular Diseases

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ClinicalTrials.gov Identifier: NCT02077023
Recruitment Status : Recruiting
First Posted : March 4, 2014
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to estimate the contemporary prevalence of cardiovascular diseases in the United Kingdom (UK) and to describe the incidence and prevalence of stroke, mini stroke (TIA), Heart Attack (MI), deaths and interventions repairs for carotids and occlusive arterial disease in a large population. This study will also allow us to obtain reliable information on the age- and sex-specific relevance of tobacco and alcohol consumption, obesity, diabetes and blood pressure as risk factors for different cardiovascular diseases. By following up a large group of participants for 5 years, we will be able to estimate the annual risk of stroke and other CVD events associated with asymptomatic carotid artery stenosis and atrial fibrillation.

Condition or disease
Stroke Heart Attack TIA Cardiovascular Diseases

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Study Design

Study Type : Observational
Estimated Enrollment : 5200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Natural History of Cardiovascular Diseases
Study Start Date : February 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Asymptomatic Carotid Artery Disease, AF


Outcome Measures

Primary Outcome Measures :
  1. The contemporary prevalence of asymptomatic carotid artery disease and atrial fibrillation by age and sex and natural history of stroke associated with asymptomatic carotid lesion and atrial fibrillation identified by screening [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Effect of a targeted, comprehensive and cost-effective cardiovascular screening programme on a number of participants with adverse events [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study consists of an observational, prospective study of the prevalence of and risk factors for AF, CAS and stroke amongst 5,200 people who voluntarily attended cardiovascular screening appointments provided by Life Line Screening.

This cohort will include 1300 participants who are exposed to significant carotid artery stenosis (more than 50% artery occlusion identified by ultrasound scan) and atrial fibrillation. We also aim to recruit 3900 participants who do not have carotid artery disease or atrial fibrillation as control group and for comparison purposes. The control group will be drawn from a population that is similar to the exposed group in all respects other than their carotid disease and atrial fibrillation. The data collected for the control group will be the same and will be obtained in the same way as those on the exposed group.

Criteria

Inclusion Criteria:

  • Participants who underwent self-selected, private screening program held by Life Line Screening
  • Adult participants over the age of 20
  • Participants who filled in appropriate health questionnaire and signed relevant consent part of their questionnaire
  • Cohort observation cases: participants with significant carotid artery disease (>50% stenosis) detected by duplex ultrasound and/or AF
  • Cohort observation controls: Participants without CAS detected by Duplex ultrasound or AF

Exclusion Criteria:

  • Those who are unable to give informed consent
  • Participants under 20 years old
  • Participants who filled in the health questionnaire incompletely
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077023


Contacts
Contact: Mohssen Chabok, MD mc609@imperial.ac.uk

Locations
United Kingdom
Imperial College London Recruiting
London, United Kingdom, SW7 2AZ
Principal Investigator: Mohssen Chabok, MD         
Sponsors and Collaborators
Imperial College London
University of Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Investigators
Principal Investigator: Mohssen Chabok, MD Imperial College London
Study Director: Mohammed Aslam, PhD Imperial College London
More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02077023     History of Changes
Other Study ID Numbers: 13IC0865
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: September 2014

Keywords provided by Imperial College London:
Stroke
Heart Attack
Asymptomatic Carotid Artery Disease
Atrial Fibrillation

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Vascular Diseases