Effect of the SCOT-HEART 2 Trial on Lifestyle.

Coronary Artery Disease Clinical Trial

Official title:

Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156061
• Other study ID #: AC19113
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: July 12, 2024

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: Mohammed N Meah, MB ChB
• Phone: 07921238123
• Email: m.meah[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a sub-study of the SCOT-HEART 2 trial (which aims to determine the best way to prevent heart attacks).

The purpose of this sub-study is to determine the effect of getting information on heart disease risk on lifestyle. At present doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the SCOT-HEART 2 study the investigator will compare this "risk score" to a specialised heart scan (a computed tomography coronary angiogram or CTCA scan). In this study the investigator would like to understand more about the effects of receiving this information about the heart on lifestyle, including effects on smoking, diet and activity.

This study will recruit 400 participants who are taking part in the SCOT-HEART 2 trial. The investigator will assess lifestyle by using a detailed questionnaire which will be done at the start of the study and 6 months later. The investigator will also perform some simple investigations including a carbon monoxide breath test, blood pressure tests and measurements of activity such as step counts. This will help us understand the effects on lifestyle of getting information about a "risk score" or having a CT scan. In addition, for people who have CT scans the investigator will either provide a verbal explanation of the results, as is usual, or show pictures of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to partipants.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Primary Prevention

Intervention

Other:
• Delivery of CT scan results
Method of results delivery - verbal or visual.

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh	Midlothian

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

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