Informed Consent Form Version number 1.0 September 2005
THIS SHEET HAS BEEN APPROVED BY THE WEST ETHICS COMMITTEE INFORMATION SHEET FOR PATIENTS/VOLUNTEERS IN CLINICAL RESEARCH PROJECT
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide
whether or not you wish to take part.
Thank you for reading this.
Brief Title of Project
Resistance to antiplatelet therapy in patients undergoing PCI. A pilot study.
What does this title mean?
We know that blood clots are responsible for heart attacks and strokes. They also occur when patients have stents placed in narrowed arteries (Percutaneous Coronary Intervention , PCI) and may cause damage to the heart during these procedures. We give aspirin and another similar medication called clopidogrel (antiplatelet therapy) to help prevent clots forming and thus the risk of heart attacks, strokes and damage to the heart during and after PCI. However, some patients still experience events. This may be due to resistance to the effects of these therapies.
What is the purpose of the study?
The purpose of this study is to establish that we can measure variations in an individual’s response to aspirin and clopidogrel using simple blood tests. This would be done before you undergo PCI and again following the procedure. We would also like to record the amount of damage to the heart muscle after stents have been placed in the narrowed heart arteries. We can measure the amount of damage using a blood test. Importantly none of these tests will affect the drug or stent treatment you receive
The follow-up will be for 12 months at which point you will be telephoned to establish whether you have had any further problems since the procedure was done.
Page | 210 Our hope is that if we can detect patients who are resistance to antiplatelet therapy and,
therefore, at higher risk of complications from PCI, we can alter their medication to help reduce this risk.
Why have I been chosen?
You have been chosen to take part in this study because you have had symptoms (such as chest pain), an exercise test or blood tests that suggest you have narrowings in the heart arteries. You may have already had an special x-ray test called an angiogram to confirm this.
Your consultant has suggested that you have balloons and stents placed in you arteries to relieve the narrowings.
You are already taking aspirin regularly to try and prevent clots forming in the arteries of the heart. You will also be given another tablet called clopidogrel before you undergo this
procedure again to help prevent the formation of blood clots. We want to test your blood to see how well these medications are working before and after you have the procedure.
We intend to recruit 40 patients all of whom will undergo the same blood tests.
Do I have to take part?
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 and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.
What will happen to me if I take part?
If you are interested in taking part, we will assess your suitability by means of a review of your case notes and previous investigations at the time of your attendance at clinic or whilst on the ward.You will then be asked to read this information leaflet and be given time to decide whether you wish to take part in the study.
All patients who agree to take part in the study, after providing their written consent, will have a full medical history taken, including all medications. They will also undergo a brief physical examination. This should take no more than 15 minutes. We will then carry out a blood test (approx. 2 tablespoons) while you are taking aspirin alone, to check for response to this therapy. (Blood samples will be drawn from the arm and should cause no more than a small jagging sensation. You would have a blood test at this stage as part of your normal care.) You will then be given clopidogrel as part of the standard preparation prior to PCI.
Immediately before you undergo the procedure we will perform a further blood test to check the response to clopidogrel therapy and the amount of heart damage markers in your blood.
You will then undergo the procedure with placement of heart artery balloons and stents. None of the tests we have done will affect the procedure you have done.
Page | 211 If you do not have any balloons or stents placed in the arteries of the heart then we shall thank you for your participation in this study and nothing else shall be required to be done.
If you have balloons or stents then the day after the procedure we will do a further blood test to check for damage to heart muscle and again measure the response to clopidogrel treatment.
You would have a blood test at this stage as part of your normal care.
We will telephone you at home a year after your PCI and ask a few questions regarding your general health, medications and any health problems you have had in this period of time. This should take no more than 10 minutes.
This study does not involve any experimental treatment, there are no restrictions to your lifestyle, and you should continue to live as you normally would.
Flow Chart of Study Design
Eligible Patient Intended to Undergo PCI ASPIRIN 75mg/day
Clinic Visit/On Ward Before PCI
Blood tests for response to Aspirin.
Start Clopidogrel (Antiplatelet)
Day of procedure.
Blood tests for:
1. Response to Clopidogrel.
2. Heart damage markers PCI
Day after procedure.
Blood test for:
1. Response to Clopidogrel 2. Heart damage markers
Page | 212 What are the side effects of any treatment received when taking part?
There are no additional treatments given as part of this study.
What are the potential risks or disadvantages to me if I have these tests performed?
Having your blood taken is occasionally uncomfortable and some people may feel faint.
There is a small risk of bleeding, bruising or infection at the puncture site following the blood test.
What are the possible benefits of taking part in this study?
You may not benefit directly from taking part in the study, however the information that we get from this study may help us to improve the treatment of future patients undergoing PCI and may help prevent heart attacks and strokes.
You will not be paid for taking part in this study.
What happens if new information becomes available?
Sometimes during the course of a research project, new information becomes available about the condition being studied. If this happens, your research doctor will tell you about it and discuss with you whether you want to continue in the study, or whether it might be in your best interest to withdraw, or be withdrawn from the study.
What if something goes wrong?
If you are harmed as a result of taking part in this study, there are no special compensation arrangements. If you are harmed as a result of someone’s negligence, then you may have grounds for legal action, but you may have to pay for it.
If you wish to complain, or have any concerns about the way you have been treated during the course of this study, the normal National Health Service complaints mechanisms will be available to you.
Do I have to take part?
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 and without giving a reason.
A decision to withdraw at any time, or a decision not to take part, will not affect your medical care in any way, either now, or in the future.
If you are, or are likely to become, pregnant you should not participate in the study.
Will my taking part in this study be kept confidential?
Page | 213 All information which is collected during the course of the research will be kept strictly
confidential. Any information which leaves the hospital/surgery will have your name and address removed so that you cannot be recognised from it.
If you decide to take part in this study, your General Practitioner will be advised of your participation and the tests that you will undergo.
What will happen to the results of the research study?
When the final results become available, they will be submitted to medical journals (magazines) where they will be considered for publication. The final results will also be submitted to national and international medical conferences, where they will be considered for presentation.
If you would like a copy of the results, please ask your study doctor.
Who is organising and funding the research?
This research has been sponsored by the West Research Endowments Fund. The medical staff receive no payment for including you in the study.
Who has reviewed the study?
This study has been reviewed by the local Research Ethics Committee. More details can be provided, on request, by your study doctor.
Who can I contact to get more information about this study?
You are encouraged to ask questions at any time during the study.
Please contact:-
Study Doctor: Dr Richard IS Good
Cardiology Research Unit 0141-211 6390 Supervisor: Dr Keith G Oldroyd 0141 211 2337 Independent Doctor: Dr Stephen D Robb 0141 211 1903 Thank you for taking the time to read this patient information leaflet.
You should be given a copy of this and the signed consent form to keep.
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