Researcher’s institutional letterhead



PARTICIPANT INFORMATION SHEET

CLINICAL TRIAL

Coronary Artery calcium score: Use to Guide management of Hereditary Coronary Artery Disease (CAUGHTCAD)

Invitation

You are invited to participate in a research study to identify whether an X-ray based scan is able to improve the diagnosis and prevent progression of coronary artery disease (CAD) in people with a family history of CAD in middle age.

The study is being conducted by;

• Prof Tom Marwick, Kristyn Whitmore RN, Dr Faraz PathanKazuaki Negishi, Menzies Research Institute Tasmania, Hobart, TAS.

• Dr Catherine Jones, Regional Imaging, Hobart, TAS.

The study is part of a national collaborative study coordinated by the Menzies Research Institute Tasmania. Other investigators are in Adelaide, Perth, Melbourne and Brisbane.

Before you decide whether or not you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.

1. ‘What is the purpose of this study?’

People who have a relative who developed CAD in middle age (under the age of 60 in a close relative eg. parent, brother, sister, or under the age of 50 for other relatives such as uncles, aunts, grandparents) are at increased risk of developing CAD. The existing methods used for detection of risk (eg. the Australian absolute cardiovascular disease risk calculator, ) does not incorporate family history of coronary artery disease. The aims of this study are to examine the effectiveness of an X-ray scanning approach to improving risk assessment in people with a family history of CAD, and to see whether initiation of treatment can prevent progression of CAD. Sensitive measures of the amount of artery wall thickening (atheroma) will be compared before and after this process, using coronary CT angiography, and X-ray test that is performed with X-ray contrast.

2. ‘Why have I been invited to participate in this study?’

You are eligible to participate in this study because you have a family member with CAD onset in middle age.

3. ‘What if I don’t want to take part in this study, or if I want to withdraw later?’

Participation in this study is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, it will not affect the treatment you receive now or in the future. Whatever your decision, it will not affect your relationship with the staff caring for you.

New information about the treatment being studied may become available during the course of the study. You will be kept informed of any significant new findings that may affect your willingness to continue in the study. If you wish to withdraw from the study once it has started, you can do so at any time without having to give a reason.

4. ‘What does this study involve?’

If you agree to participate in this study, you will be asked to sign the Participant Consent Form.

All participants in this study will undertake an X-ray (CT) scan for calcium at baseline. Some people will have very low levels of calcium (no treatment is warranted) and others will have very high levels (treatment is needed). People with scores in between will be suitable for the study and will undergo a coronary CT angiogram and give some blood samples (about one tablespoon of blood). This is a test based on X-ray dye that shows any narrowings in the coronary arteries. Again, any subjects with a serious narrowing will be excluded as treatment is needed.

All other participants will be randomised (see definition below) to either take the medication atorvastatin, one tablet daily (one 40 mg tablet each day),or no medication. If you suffer from side effects from Atorvastatin the alternative medication is Rosuvastatin or Pravastatin, in discussion with the cardiologist. The aim is to identify whether there is a favorable effect from the statin on progression of the amount of plaque, which is a marker of risk of later events.

We will follow the response of your heart and arteries at the end of the treatment period by taking another CT scan of the heart.

Definition

‘Randomised trial’:

Sometimes doctors don’t know the best way of treating patients with a particular condition so comparisons need to be made between different treatments. To do this, study participants are put into groups and given different treatments, and the results are compared to see whether one treatment is better. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, like the flip of a coin. Neither the doctor nor the study participant can decide which treatment the participant receives.

If you agree to participate in this trial, you will then be asked to undergo the

following procedures:

• Cardiac CT for calcium and CT coronary angios.

• Blood sample for cholesterol.

In addition, the researchers would like to have access to your medical record to obtain information relevant to the study.

The follow up process will involve the clinical evaluation at 3,6,12,24 and 36 months. Blood tests and assessment of any adverse events will occur every 6 months, and we will follow the response of your heart and arteries at the end of the treatment period by taking another CT coronary angios of the heart. We would also like to ask your permission to obtain access to your records and/or contact you for follow up over the next 10 years.

5. ‘How is this study being paid for?’

The study is being supported by a medical research funding body that is not a commercial entity and has no financial interests in the study findings. None of the investigators have any duality or conflict of interest. All of the money being paid to run the trial will be deposited into an account managed by the institution of chief investigators. No money is paid directly to individual researchers.

6. ‘Are there risks to me in taking part in this study?’

The CT scans are a source of Xray exposure, and there is concern that this could be harmful. The radiation dose of a coronary CT scan is ~2 mSv, equivalent to 20 chest X-rays. The risk of cancer from this dose in a 55 year old man is 0.0088%, meaning that 1 in 11346 men might develop cancer due to this test. In a 55 year old woman it would be 0.011%, meaning that 1 in 8768 women might develop cancer due to this test ().

Atorvastatin, Rousvastatin and Pravastatin are allis approved for treatment of high cholesterol and reduction of cardiovascular risk in Australia. AtorvastatinIt has been used extensively for about 20 years and is generally safe and well tolerated.

Those randomised into the group receiving medication will be prescribed Atorvastatin (40mg tablet) beyond the current Australian treatment guidelines, the intention being to determine at the end of the study whether or not they have benefited in comparison to those not taking the medication. Atorvastatin (or alternative statin therapy) will be provided to participants at no cost for the duration of the study.

The most common side-effects of statin therapy are muscle ache, but these can usually be controlled by changing dose (first reducing to 20mg, then 10mg if required) or by switching to another statin agent such as Rosuvastatin 10mg or Pravastatin. Other side effects of the statin agents seen in ................
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