Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-31 @ 7:24 AM
Study NCT ID:
NCT04156061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2019-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the SCOT-HEART 2 Trial on Lifestyle.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications', 'timeFrame': '6 months', 'description': 'The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)'}], 'secondaryOutcomes': [{'measure': 'Smoking cessation', 'timeFrame': '6 months', 'description': 'Proportion of patients who changed smoking habits (%)'}, {'measure': 'Weight loss', 'timeFrame': '6 months', 'description': 'Measure change in weight via body mass index and waist circumference (%)'}, {'measure': 'Blood pressure control', 'timeFrame': '6 months', 'description': 'Change in blood pressure control through lifestyle/compliance with medications (%)'}, {'measure': 'Lipid levels', 'timeFrame': '6 months', 'description': 'Change in serum lipid levels through lifestyle/compliace with medications (%)'}, {'measure': 'Diabetic control', 'timeFrame': '6 months', 'description': 'Change in glycosylated haemoglobin (HbA1c) (%)'}, {'measure': 'Adherence to medications', 'timeFrame': '6 months', 'description': 'Change in compliance with medications tracked through questionnaire'}, {'measure': 'Exercise', 'timeFrame': '6 months', 'description': 'Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire'}, {'measure': 'Quality of life/Anxiety and Depression', 'timeFrame': '6 months', 'description': 'Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)'}, {'measure': 'ASSIGN score', 'timeFrame': '6 months', 'description': 'Change in ASSIGN score as a result of lifestyle / risk factor modification (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Primary Prevention']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a sub-study of the SCOT-HEART 2 trial (which aims to determine the best way to prevent heart attacks).\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MUST BE ENROLLED IN SCOTHEART 2 TRIAL\n\nExclusion Criteria:\n\n* MUST BE ENROLLED IN SCOTHEART 2 TRIAL'}, 'identificationModule': {'nctId': 'NCT04156061', 'briefTitle': 'Effect of the SCOT-HEART 2 Trial on Lifestyle.', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.', 'orgStudyIdInfo': {'id': 'AC19113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'ASSIGN score', 'description': 'The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments.\n\nPatients randomised to standard care with ASSIGN score alone (n=200) will be invited back approximately 6 months after baseline assessment. The detailed questionnaire, breath test, blood pressure monitoring, and 2-week activity monitor will be repeated. Bloods will be retaken to look at change in lipid levels and HbA1c where appropriate - no more than 30mls will be required.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CTCA - visual report', 'description': 'Those in the CTCA group will be further randomised into review with or without CT images.\n\nThe review WITH images (VISUAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.', 'interventionNames': ['Other: Delivery of CT scan results']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CTCA - verbal report', 'description': 'The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments.\n\nThose in the CTCA group will be further randomised into review with or without CT images.\n\nThe review WITHOUT images (VERBAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.', 'interventionNames': ['Other: Delivery of CT scan results']}], 'interventions': [{'name': 'Delivery of CT scan results', 'type': 'OTHER', 'description': 'Method of results delivery - verbal or visual.', 'armGroupLabels': ['CTCA - verbal report', 'CTCA - visual report']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'state': 'Midlothian', 'country': 'United Kingdom', 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'To be determined', 'ipdSharing': 'YES', 'description': 'Anonymised participant data will be made available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Heart Foundation', 'class': 'OTHER'}, {'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}