Plain English Summary
Background and study aims
Cardiovascular disease (heart attacks, strokes and peripheral vascular disease) remains the leading cause of death and disability in Western societies despite advances in how we treat these conditions. Preventing them from developing is better than treating them once they have presented themselves. Medical treatment, including with statins, is known to reduce the risk of cardiovascular events but drugs also have a cost both financially and in terms of side effects. Therefore it is best to target their use in people who are most likely to benefit. Currently doctors in the United Kingdom use tools based on observational studies to estimate an individual's risk of developing cardiovascular disease. This is then used to decide who to recommend preventative medication to. However, these tools are not accurate: many people estimated to be at low risk and therefore not offered treatment develop cardiovascular disease. In hindsight these people may benefit from treatment if they could be accurately identified as being at increased risk. This study is investigating the ability of a new screening programme involving blood tests and a magnetic resonance imaging (MRI) scan to identify people at increased risk of cardiovascular disease.
Who can participate?
Men and women in Tayside, Scotland, aged 40 years or older, free from cardiovascular disease (e.g., heart attacks, strokes, angina) and without an indication for preventative medication (e.g., statins) under current clinical guidelines.
What does the study involve?
Participants are assessed for their current estimated risk by taking a clinical and family history, measurement of blood pressure, weight, height, and smoking, dietary and exercise habits. Blood is taken to determine blood cholesterol and glucose levels. Blood is also analysed to check the level of B-type natriuretic peptide (BNP). Increased levels of this substance indicate that there may be some stress on the heart or vascular system. If participants are found to have a higher than average level of BNP (which may still be 'normal') they are invited to attend for an MRI scan at the Clinical Research Centre at the University of Dundee at Ninewells Hospital. This involves a scan of the heart and arteries throughout the body to look for an increased size of the heart or narrowing of the arteries. The scan involves the injection of a 'contrast' liquid into a vein to make the pictures clearer. All participants (whether they are invited for a scan or not) are followed up by their computerised health records to see if they develop cardiovascular events or disease such as heart attacks, strokes, angina and peripheral arterial disease, as well as other outcomes such as death and prescriptions of relevant medication. The study does not involve giving any medication; however, if during assessment for the study a participant is found to have a reason to start medication as advised by current guidelines that individual and their General Practitioner (GP) will be advised of this recommendation.
What are the possible benefits and risks of participating?
Potential benefits from taking part include possible identification of previously unrecognised risk factors for cardiovascular disease. This will lead to advice to address these risk factors with medication if required. Taking part in the study will help further doctors' understanding of cardiovascular disease and may help develop future screening programmes to identify people at risk of cardiovascular disease. This has the potential to improve how we target preventative medication and could save lives. The MRI scan involves injecting a contrast liquid into a vein. A small number of people may have an allergic reaction to this which could range from a brief local reaction (itch and rash) to a more severe reaction. If this unlikely event occurs medical staff will be available to treat it. A small number of participants may have previously undiagnosed disease, such as cancers, that may be picked up incidentally during the MRI scan.
Where is the study run from?
The study is being run from the University of Dundee at Ninewells Hospital and Medical School.
When is the study starting and how long is it expected to run for?
The first participant will be recruited in November and we aim to complete recruitment of 5000 volunteers by January 2013. Follow up by looking at computerised health records will be initially 2 years after the participant joins the study and then at 5 and 10 years.
Who is funding the study?
The study is being funded by a grant from the Souter Charitable Trust, and Chest, Heart and Stroke Scotland.
Who is the main contact?
Dr Roberta Littleford, TASCFORCE Trial Manager, Division of Cardiovascular and Diabetes Medicine, Medical Research Institute, University of Dundee, Ninewells Hospital and Medical School, Dundee. DD1 9SY.
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jill Belch
ORCID ID
Contact details
The Institute of Cardiovascular Research
Vascular and Inflammatory Diseases Research Unit
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383092
j.j.f.belch@dundee.ac.uk
Additional identifiers
EudraCT number
2007-002010-19
ClinicalTrials.gov number
Protocol/serial number
Protocol no.: TASC07; MHRA: 020807
Study information
Scientific title
The TASCFORCE Project: Tayside Screening For risk of Cardiac Events
Acronym
TASCFORCE
Study hypothesis
Current hypothesis as of 09/01/2014:
That screening an at-risk population by magnetic resonance imaging for early signs of cardiovascular disease as measured by left ventricular mass and whole body atheroma burden will predict future cardiovascular events.
Previous hypothesis:
That screening an at-risk population by magnetic resonance imaging for early signs of heart disease as measured by left ventricular mass combined with a statin intervention in the high risk group will prevent heart attack stroke and the associated mortality.
On 09/01/2014 the following changes were also made to the trial record:
1. The public title was changed from 'The TASCFORCE Project: Tayside Screening For risk of Cardiac Events and the effect of statin on risk reduction' to 'The TASCFORCE Project: Tayside Screening For risk of Cardiac Events'
2. The study design was changed from 'Double-blind randomised placebo-controlled trial' to 'Prospective normal volunteer cardiovascular risk screening study'
On 28/02/2014 the overall trial end date was changed from 01/06/2007 to 01/02/2023.
Ethics approval
Tayside Committee on Medical Research Ethics B,13/07/2007, ref: 07/S1402/42
Added 09/01/2014: Current protocol with amendments approved 26/09/2011
Study design
Prospective normal volunteer cardiovascular risk screening study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prevention of cardiovascular events in at-risk population
Intervention
Current interventions as of 27/02/2014:
All participants will receive lifestyle counselling and leaflets on modifiable risk factors.
The baseline observations are: height, weight, BMI, total cholesterol, HDL, LDL, triglycerides, glucose, BP, heart rate, B-type natriuretic peptide (BNP), ECG, smoking history, family history of cardiovascular disease.
For those with an elevated BNP: a whole-body contrast-enhanced MRI scan. This will be used to determine left ventricular mass, whole body atheroma burden and presence of myocardial delayed enhancement to indicate cardiac ischaemia.
Follow up (for all participants) via record linkage will be for mortality, hospital admissions (with diagnosis), new diagnoses of cardiovascular disease, prescribing data. This will initially be at 2 years after recruitment and will continue for up to 10 years.
Previous interventions:
Simvastatin 40 mg daily versus placebo for 18 months to 2 years, and then all participants will receive life style counselling and leaflets on modifiable risk factors at one 15-minute session.
Intervention type
Drug
Phase
Not Applicable
Drug names
Simvastatin
Primary outcome measure
Current primary outcome measures as of 09/01/2014:
Ability of increased left ventricular mass as detected by MRI scan to predict future cardiovascular events
Previous primary outcome measures:
Left ventricular mass at two years
Secondary outcome measures
Current secondary outcome measures as of 09/01/2014:
1. Ability of BNP level to predict future cardiovascular events
2. Ability of MRI-derived whole body atheroma burden to predict future cardiovascular events
Previous secondary outcome measures:
Validation of the magnetic resonance imaging (MRI) screening tool as a predictor of cardiovascular disease
Overall trial start date
01/06/2007
Overall trial end date
01/02/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Men and women aged 40 years and over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5000
Participant exclusion criteria
1. Known atherosclerotic disease
2. Indication for statin therapy according to current clinical practice
3. Known primary muscle disease
4. Contraindication to statin
5. Any serious illness that may compromise the subjects safety or completion of study
6. Any illness which means that the subject is unable to give informed consent
7. Known alcohol abuse
8. Drinking more than two glasses of grapefruit juice per day
9. Pregnancy and not using reliable method of contraception
Recruitment start date
01/06/2007
Recruitment end date
01/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Institute of Cardiovascular Research
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
c/o Mr James Houston
Research and Innovation Services
University of Dundee
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 384664
j.z.houston@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Chest, Heart and Stroke Scotland (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added 28/02/2014: Souter Charitable Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list