Frequently asked questions

1. What is an aortic dissection?

2. What is a randomized controlled trial?

3. What is the SUNDAY Trial trying to answer?

4. Is this treatment new or experimental?

5. What centers are involved in this trial?

6. How long will it take to carry out this trial?

7. What are my rights as a participant in the SUNDAY Trial?

8. What happens to my data?

9. Are there any benefits?

10. Why am I not part of this trial?

11. Is this trial safe?

12. What if something goes wrong?

13. When can I know the results?

1. An aortic dissection is tear in the aorta, the large blood vessel that goes from the heart and to the rest of the body, that comes suddenly and can be extremely painful. Typically, the pain is felt in the back, between the shoulders, but it can also present as chest pain or even abdominal pain. What happens afterwards is unpredictable, but medical evaluation and admission is essential. Many tests and imaging are required. A medical team will discuss immediate treatment and, depending what the tests show, surgical intervention may be required immediately, although sometimes it is preferred to wait. In medical terminology, an aortic dissection is considered complicated if the dissection is life threatening or if the various symptoms are intolerable.

An aortic dissection may also be considered as uncomplicated, which does not necessarily mean that it is not dangerous, but that danger does not appear to be imminent or life threatening. When one speaks of surgical intervention, this is typically in reference to something called TEVAR, which stands for thoracic endovascular aortic repair. This is a stent that is placed in the aorta, and it is designed to cover the tear in the aorta and reduce pain and prevent further growth of the tear and damage to the aorta.

2. A randomized controlled trial is any trial that randomizes one treatment, one test, or any one thing against another. It is considered as the Gold Standard in determining what works and what does not, as the process is entirely random and not predicated on individual influences or preferences. It should be stressed that a randomized controlled trial in no way means that any relevant or appropriate treatment will be compromised. A randomized controlled trial will randomize one aspect of treatment, but the safety and recommended treatment of individuals are still the priority.

3. The SUNDAY Trial is an acronym for the Scandinavian trial of UNcomplicateD AorticDissection TherapY. It is asking the question of whether early intervention improves survival for patients who have experienced an uncomplicated aortic dissection. The term uncomplicated is somewhat vague but is usually rendered by the clinical team and is based on your symptoms and various medical tests and imaging. In some cases, the dissection is considered complicated, and this most often requires some form of surgical intervention. An uncomplicated dissection, on the other hand, can be either treated with surgery or followed with regular medical and imaging evaluation.

Opinions regarding the most appropriate treatment vary, and it is not known with certainty whether early treatment or regular clinical follow-up is a better treatment strategy. Both have advantages, and both have risks. The SUNDAY Trial will try to answer this question. In addition to survival, we want to evaluate other important items, such as the quality of life, the costs, the safety, and any possible readmissions or reinterventions.

4. There is no new or experimental treatment, device, or medication planned in this trial. Aortic dissections are always treated with medicine and sometimes with some form of surgical intervention, and adherence to all international and national guidelines for treatment will be upheld. This trial is strictly testing whether earlier surgical intervention has an impact, which is a topic that is more or less unresolved.

5. There are many centers involved in this trial. All of them located at the large university hospital in Denmark, Sweden, Finland, Norway, and Iceland. Please visit this link to identify the hospital closest to your location

6. The trial is estimated to take approximately 3 years to recruit and involve the necessary number of participants. The necessary number of patients is based on previous reports and analyses. To date and, based on what we know, the follow-up and analysis will require a further 3-4 years, which means that any answer to our question will take somewhere between 8 and 10 years.

7. Important! Participation is entire voluntary. This mean and requires that your signature is required following a discussion and an informed consent with a member from one of the trial medical teams. All questions and concerns should be addressed, and written permission is required in order to proceed. Written material will also be provided during this process, in which your rights as a participant are detailed. It is important to repeat and stress that participation in this trial is entirely voluntary, and withdrawal from the trial is allowable at any point. It may also occur that you wish to participate in partial aspects of the trial, and these interests will be respected.

8. Any data and personal health information are retained at the local hospital and within a protected healthcare database based at Aarhus University in Aarhus, Denmark. Any information related to participants in the trial is based on a unique identifier number, and personal national identification numbers are not revealed.Efforts and adherence to the security and respect for patient privacy and autonomy have been approved by national authorities, and this includes regular and unannounced monitoring of this policy. For the purposes of data transparency and validity, data will be archived up to 15 years following cessation of the trial.

9. The benefits of participation are ultimately based on the knowledge gained from carrying out this trial. There are no financial or healthcare benefits gained by deciding to join this study. It is also important to stress that no detriments are incurred. That is, randomization to one treatment or another in no way means that an inferior treatment has been chosen. To date, either an intervention in the form of a TEVAR (a stent in your aorta) or medical and conservative therapy are considered as equivalent.

10. It may be that certain aspects of your health have automatically disqualified you from participation. If this were the case, it may not have been mentioned to you. It may, of course be, that an invitation was forgotten or neglected. Either way, if you have any questions in this regard, please contact your closest center

11. This trial has been approved by national ethical committees in every country. Inaddition, the trial has a special committee, appointed to observe the safety of all individuals involved. National health authorities also have the opportunity to evaluate and intervene at any point.

12. If something goes wrong, it is critical that you speak in depth with the treating team, the physicians, nurses, and anyone else involved. Either you or your own family physician can have this conversation. You are also welcome to contact any of the physicians from the steering committee.

13. Preliminary results from various analyses will be posted on this website. When you were invited to participate in the trial, you were also asked if you wish to be informed of any results, and these wishes will be respected. If you have any other interests or questions, you are welcome to contact either the nearest center or any member of the steering committee.