Status:
COMPLETED
Heart Attack Prevention Programme for You (HAPPY) London
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Barts & The London NHS Trust
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
40-74 years
Phase:
NA
Brief Summary
Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common and can lead to severe disability or death. Changes in the body leading to heart attacks and strokes usually...
Detailed Description
Heart Attack Prevention Programme for You London (HAPPY London) will be conducted as a randomised controlled trial comparing the use of tailored e-coaching in addition to the standard of care vs. stan...
Eligibility Criteria
Inclusion
- Subjects will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Subjects will be between 40 and 74 years of age
- Subjects will have unrestricted access to the Internet
- Subjects will be sufficiently fluent in English language.
- Subjects will have an estimated intermediate to high risk for CV events based on the web-based pre-screening tool (www.happylondon.info), which is based on the nonlaboratory Framingham risk score (\>10% 10 year cardiovascular risk)
Exclusion
- History of stroke or transient ischaemic attack (TIA)
- Cardiac sounding chest pain requiring further investigations
- Current life threatening conditions other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study
- Only for subgroup undergoing cardiac contrast-enhanced magnetic resonance studies: Any contraindication to a contrast-enhanced magnetic resonance study, such as known allergies to gadolinium-based contrast agents, severe claustrophobia, pacemakers, defibrillators, etc
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT01911910
Start Date
June 1 2013
End Date
May 1 2015
Last Update
October 12 2020
Active Locations (1)
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1
Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Queen May University of London
London, United Kingdom, E2 9JX