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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04156061
Other study ID # AC19113
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2020
Est. completion date August 30, 2023

Study information

Verified date October 2022
Source University of Edinburgh
Contact Mohammed N Meah, MB ChB
Phone 07921238123
Email m.meah@ed.ac.uk
Is FDA regulated No
Health authority
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 August 30, 2023
Est. primary completion date April 30, 2023
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

Study Design


Related Conditions & MeSH terms


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
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