What is ETTAA?
ETTAA stands for 'Effective Treatment for Thoracic Aortic Aneurysms.'
What is the study about?
ETTAA is an observational clinical trial set up to try to find the most effective treatment for a potentially fatal chest condition.
Currently there are two main forms of treatment for chronic thoracic aortic aneurysm (CTAA) - open surgery and a minimally invasive procedure called endovascular stent graft placement - however it has not been proven which is better for the patient and most cost effective for the NHS. The ETTAA study aims to answer both of these questions by observing hundreds of patients in specialist centres across the country over a period of time to see how well they do. The type of treatment patients receive will not be altered by taking part in this study.
The results from this study will enable clinicians to make a more informed decision about which treatment option will be best for individual patients.
Aims of the study:
We aim to analyse all the information collected in order to:
- Understand the growth rate of aneurysms of CTAA and identify which factors influence the growth rate.
- Understand how quality of life changes following surgical procedures
- Estimate the cost-effectiveness of the different treatment options by measuring changes in survival and quality of life of patients compared to the cost of treatment and post-operative patient care.
- Create a risk score that will help specialists determine which intervention (stenting or surgery) is best suited to a given patient and when this treatment should be offered.
What will happen to me if I take part?
If you agree to take part you will be observed from the time you agree to take part until the study concludes at the end of December 2019. No additional tests will be undertaken as part of the study, but you will be asked to complete Your treatment options will not be altered in any way by taking part in this study. Your doctor will decide on the best treatment for you. Participation in the study does not restrict your ability to change from one treatment option to another.
A more detailed explanation of what will take place is given below:
Initial review: The first visit is a baseline visit and will take up to 1 hour. A member of the research team will explain the study and you will be given the opportunity to ask any questions you might have. If you are happy to take part then you will be asked to sign a consent form. Following this you will be asked some information about your past medical history and you will complete baseline questionnaires.
If you are having a procedure you will be followed up at 1, 3, 6, 12, 18, 24 months post-surgery and annually thereafter. We will also collect data from your hospital records about your procedure and stay in hospital.
If you are having medical therapy you will be followed up 3, 6, 12, 18, 24 months after entry to the study and annually thereafter.
With your agreement, we would like to follow your health status by using the information collected on NHS Databases (e.g. Health and Social Care Information Centre). To obtain this information we will need to disclose your date of birth and national health number; these details will be treated in confidence in accordance with the data protection act.
Do I have to take part?
No. Your participation in this study is entirely voluntary. If you decide to take part you will be asked to sign a consent form. You are under no pressure to take part and may withdraw from the study if you wish at any time, without having to explain why.
Can I change my mind during the trial?
If you decide not to take part, the quality of medical and nursing care you receive will not be affected. With your permission we will keep the information we have already collected about you. You will not be contacted again about the study
Will I have extra visits to the hospital to take part?
No, if you are not due to attend the hospital all visits can be conducted over the telephone. There will be no additional visits as part of the study. The questionnaires will either be completed at your routine hospital follow-up visits; over the telephone or by post. However, your routine visits will be up to an hour longer to allow time to meet the research team and complete the questionnaires.
How will I remember how many GP visits I have had?
We have designed a patient diary that you can choose to use which may help you during the follow up visits to recall information since your last follow up. You do not have to use the diary if you do not wish.
Will my taking part in the study be kept confidential? What data goes outside the UK? Is my data anonymised?
All information that is collected abut you during the course of this study will be kept strictly confidential. Paper records regarding your case and your study number will be held securely.
Electronic information will be kept on computers that are protected by passwords.
The electronic data stored for this study will be kept on a database, but we will not keep any identifiable information. The data will be stored only under your hospital number and a unique study number which we will assign to you. The database will be stored in the USA which has lower data protection rules than the UK. However, the company storing the data has signed up to US - EU Safe Harbor Framework.
Anonymised copies of any CT scans you undertake as part of your routine care will be reviewed by a central NHS laboratory in the UK.
When the study is reported it will not be possible to identify you personally.
Representatives from regulatory authorities and the study sponsors may need to look at your medical records and the data collected in the study to check that the study was carried out correctly. Confidentiality will be maintained at all times.
What are the benefits of taking part?
There are no direct benefits to yourself from taking part in this study but the information we get may help to improve the treatment of other people with CTAA in the future.
Are there any risks involved in me taking part in ETTAA? What are the possible disadvantages and risks of taking part?
There are no anticipated disadvantages or risks involved in this study as it is an observational study of NHS care for patients with CTAA.
Can I contact someone directly to ask about the trial?
In the first instance please contact:
Papworth Hospital Research Team on 01480 364980
Which NHS Trusts are participating?
Please refer to the recruiting centres section for a full list of the Trusts taking part in this study.
Will I be informed of the results of the study afterwards?
The results of the study will be published in scientific journals and presented at scientific meetings. A summary will also be published on clinicalstrials.gov which is a publically accessible website. You will not be identified in any report/publication.
Who is organising and funding the research?
The study is being organised and run by Papworth Hospital NHS Foundation Trust and funded by the National Institute for Health Research Health Technology Assessment (HTA) Programme.
The doctor and the research teams conducting the research are not receiving additional payments for including you in this study.
Who has reviewed the study?
This study was reviewed and approved by a group of independent experts from the National Institute for Health Research.
All research carried out in the NHS is assessed by an independent committee who make sure that studies are scientifically and ethically sound. This study has been reviewed and given a favourable opinion by the South Birmingham Ethics Committee.
You are eligible to partake in the ETTAA study if:
- You are over 18 years old.
- You have Chronic Thoracic Aortic Aneurysm (CTAA) larger than or equal to 4cm on the arch or descending aorta
- You are able to give informed consent.
You are unable to take part in the ETTAA study if:
- Intervention required below the level of the coeliac axis
- You have acute dissection or malperfusion syndromes (such as myocardial infarction, acute stroke or limb ischaemia)
See NIHR ETTAA website fro more details.