An Observational Study of Natural History of Cardiovascular Diseases

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Imperial College London
Sponsor:
Collaborators:
University of Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT02077023
First received: February 5, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to estimate the contemporary prevalence of cardiovascular diseases in the 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
Stroke
Heart Attack
TIA
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Natural History of Cardiovascular Diseases

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of a targeted, comprehensive and cost-effective cardiovascular screening programme on a number of participants with adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 5200
Study Start Date: February 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asymptomatic Carotid Artery Disease, AF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077023

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

Locations
United Kingdom
Imperial College London Not yet 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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02077023     History of Changes
Other Study ID Numbers: 13IC0865
Study First Received: February 5, 2014
Last Updated: February 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Stroke
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014