Coronary Artery Disease Clinical Trial
Official title:
Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.
This study will recruit 400 participants who are taking part in the Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (SCOT-HEART 2) trial. The investigator will assess diet, activity and habits at the start of the study and 6 months later. This will help us understand the effects taking part in the study may have on lifestyle. In addition, for participants who have CT scans, the investigator will present the results of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to patients.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | July 12, 2024 |
Est. primary completion date | January 12, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: - MUST BE ENROLLED IN SCOTHEART 2 TRIAL Exclusion Criteria: - MUST BE ENROLLED IN SCOTHEART 2 TRIAL |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Edinburgh | Edinburgh | Midlothian |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | British Heart Foundation, NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications | The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%) | 6 months | |
Secondary | Smoking cessation | Proportion of patients who changed smoking habits (%) | 6 months | |
Secondary | Weight loss | Measure change in weight via body mass index and waist circumference (%) | 6 months | |
Secondary | Blood pressure control | Change in blood pressure control through lifestyle/compliance with medications (%) | 6 months | |
Secondary | Lipid levels | Change in serum lipid levels through lifestyle/compliace with medications (%) | 6 months | |
Secondary | Diabetic control | Change in glycosylated haemoglobin (HbA1c) (%) | 6 months | |
Secondary | Adherence to medications | Change in compliance with medications tracked through questionnaire | 6 months | |
Secondary | Exercise | Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire | 6 months | |
Secondary | Quality of life/Anxiety and Depression | Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%) | 6 months | |
Secondary | ASSIGN score | Change in ASSIGN score as a result of lifestyle / risk factor modification (%) | 6 months |
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