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PARTICIPANT INFORMATION SHEET
PRESERVE: How intensively should we treat blood pressure in established
cerebral small vessel disease?
You are invited to participate in a research project we are running to try to find out how intensively
we should treat blood pressure in patients with established cerebral small vessel disease. Before
you decide whether to take part it is important that you understand why the research is being
done and what it will involve. Please take time to read the following information sheet carefully
and discuss it with friends, relatives, and your GP if you wish.
Do ask us if there is anything that is not clear to you or if you would like more information.
1. What is the purpose of the study?
Disease of the small blood vessels in the brain, which is called cerebral small vessel disease
(SVD), causes a fifth of all strokes and is the major cause of dementia. High blood pressure
(hypertension) is the major risk factor for this disease but we do not know how intensively we
should treat blood pressure in people who have already developed the disease. Reducing the
blood pressure to lower levels may delay progression of the disease; on the other hand leaving
blood pressure slightly higher may increase blood flow to the brain and improve cognition. We are
carrying out this study to find out how best to treat blood pressure in patients with this disease
In the study we will compare whether lowering blood pressure more than we usually do results in
less people suffering cognitive problems over a two year period. One group will have blood
pressure reduced to normal levels (standard therapy). The other will have blood pressure reduced
further to slightly lower levels (intensive therapy).
In some hospitals, including this one, we are also carrying out an MRI study in which we are using
MRI to assess the amount of brain damage and blood flow to the brain and seeing whether one of
the two treatments is better at reducing brain damage and increasing blood flow to the brain.
2. Why have I been chosen?
You have been chosen because you have cerebral small vessel disease.
3. Do I have to take part?
Your participation in the study is entirely voluntary. It is up to you to decide whether or not to take
part. If you do decide to take part you will be given this information sheet to keep and be asked to
sign a consent form. If you decide to take part you are still free to withdraw at any time without
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giving a reason. If you decide not to take part in the study, the standard of care you receive will
not be affected.
4. What will happen to me if I take part?
To find out whether intensive treatment is better than standard treatment, half of the patients
entering the main study will be allocated to intensive treatment and half to standard treatment.
Which treatment you are allocated to will be decided by a computer. This random allocation is
important if we are to determine fairly which of the two treatments is better.
The study involves several visits to the hospital. You will need to come in at the beginning of the
study and again after 1, 3, 6, 12, 18 and 24 months. You will have a clinical assessment (review
of medication and blood pressure) at each visit and cognitive assessments (memory type tests) at
some visits. At the initial visit and at 12 and 24 months, we will also need to speak to a carer,
family member or other person who knows you well enough to answer questions about your daily
activities.
At the beginning of the study you will be given a blood pressure monitor to take home, you will be
asked to perform daily blood pressure readings for three days before pre-arranged phone calls
which you will receive every two weeks. These calls are to make sure that your blood pressure is
within a certain range and to see if you need to have your medication altered. If it needs to be
altered, the dose may be changed over the phone if possible, however, if a new medication is
required, you will need to visit for a prescription.
When you enter the study, you will have a blood sample taken.
If you are involved in the MRI sub-study you will have an MRI scan at the beginning and at 24
months.
Wherever possible these will take place when you are visiting for the main study
assessments. In addition, people in the blood flow additional study will have a further MRI scan at
3 months.
5. What will happen to my blood sample?
Your sample will firstly be stored at the hospital you visit and will later be transferred to the
research centre at Cambridge University Hospitals for long term storage. This will be used to see
if we can discover whether there are reasons (such as genetic factors) that make some people
more likely to get this disease and to respond better to blood pressure treatment than others.
Extracted DNA samples may be sent for additional testing to other centres in the UK or Europe for
specific analyses as part of future collaborative projects. This will be done anonymously and you
will not receive results of these tests.
6. What are the possible disadvantages and risks of taking part?
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Blood sampling: Some bruising and discomfort can occasionally occur after having blood taken.
MRI: This will only be performed if you are in the sub-study. This is a painless and safe brain
scanning technique. It involves lying down with your head in a tunnel. You then lie still and
intermittently hear loud noises from the scanner. Some people find this claustrophobic, but the
scanner has an intercom so that you can talk to the doctors and stop the scan at any time. You
can also have a panic button if you wish, which will stop the scan at any time.
7. What are the possible benefits of taking part?
All patients taking part in the study will receive careful follow-up.
8. What if something goes wrong?
Any complaint about the way you have been dealt with during the study or any possible harm you
might suffer will be addressed. If you have a concern about any aspect of the study, you should
ask to speak to the researchers who will do their best to answer your questions. If you remain
unhappy and wish to complain formally, you can do this through the Cambridge University
Hospitals NHS Complaints Procedure by telephoning PALS on 01223 216 756. Details can also
be obtained from the hospital.
In the event that something goes wrong and you are harmed during the research, and this is due
to someone’s negligence, then you are protected by indemnity insurance provided by the
University of Cambridge. Details of this insurance can be obtained from the University of
Cambridge Insurance Section, Greenwich House, Madingley Rise, Madingley Road, Cambridge
CB3 0TX or by telephoning 01223 332216. If you are harmed and negligence has not occurred
the NHS complaints system will be available to you.
9. What will happen if there is a big change in my abilities?
This study will be occurring over two years. There is a small risk that the disease can progress
more rapidly or further strokes can occur and there is a significant decline in cognitive abilities. If
you stay in the study this will provide valuable information but in such a case we would ask for
advice regarding your continued participation from someone you have nominated at the start of
the study (usually a relative or carer).
In line with the Mental Capacity Act (2005), if participants’ ability to consent changes during the
study, we will approach a nominated individual. They will be asked to consider your feelings and
wishes and decide whether you would wish to continue to participate in the study. During your first
visit, you will be asked to provide contact information for an individual who may be asked to
provide advice in this way. We will also ask you now to give an indication of your wishes should
this occur.
10. Will my taking part in this study be kept confidential?
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Information relevant to your medical condition will be collected as part of the study. This
information will be stored at the Mental Health and Neurosciences Clinical Trials Unit at King’s
College London and at Cambridge University Hospitals NHS Foundation Trust.
All information regarding your medical records will be treated as strictly confidential and will only
be used for medical research. The data may be used for future research on stroke by other
research institutions in the UK but again your confidence will be strictly maintained.
Your medical records may be inspected by competent authorities and properly authorised
persons, but if any information is released outside the study office this will be done so in a coded
form with your name removed from the records so that your confidentiality is strictly maintained.
The results of this study will be stored on a secured computer database for a minimum of ten
years.
11. Expenses
We will be able to reimburse you for travel expenses when you come to the hospital for a visit
regarding the research.
12. Who is organising and funding the study?
The initial phase of the study has been funded by the Stroke Association and the study has been
reviewed by a number of experts selected by the Stroke Association. This study is being coordinated at Cambridge University Hospitals NHS Foundation Trust.
Thank you for taking time to consider participating in the study. If you agree to take part you will
be given a copy of this information sheet and a copy of the signed consent form.
Further information can be obtained from:
<< Insert Local PI and/or Local Study Coordinator name and contact details>>
Participant Information Sheet_MRI Centres Version 2.1 30 Jan 2014