Active not recruitingOBSERVATIONAL

BAsel Syncope EvaLuation (BASEL IX) Study

The BASEL IX study is investigating how to better understand why people faint, especially those over 40 who come into the emergency department. Fainting, or syncope, can sometimes be a sign of a serious heart problem. This research aims to develop a faster and more accurate way to figure out if fainting is due to a heart issue or something less serious. Researchers are collecting detailed patient stories, doctors' opinions, and information from new blood tests. They want to see if combining these different pieces of information helps doctors make better diagnoses and predict who might be at risk of future health problems. Participants will be followed up by phone for two years to see how they are doing after their fainting episode.

At a glance

Status

Active not recruiting

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

3,500

Start

01 Apr 2010

Estimated completion

01 Dec 2025

Syncope

What is this study about?

Fainting, also known as syncope, is when you suddenly lose consciousness for a short time and then recover fully. It's a common reason why people visit emergency departments. While often harmless, sometimes fainting can be a warning sign of a serious underlying heart condition. Figuring out quickly and accurately if a heart problem is causing the fainting is really important, as it can help doctors provide the right care and prevent serious health issues in the future.

This study, called BASEL IX, wants to improve how doctors in the emergency department assess people who have fainted. Currently, it can be tricky to tell the difference between harmless fainting and fainting caused by a heart problem. The researchers are looking at whether combining a careful review of your medical history, a doctor's examination, and new blood tests can help them better understand the cause of fainting. These blood tests look for specific markers in your blood that might indicate a heart issue.

The main goal is to find a better way to correctly identify if someone's fainting is due to a heart issue, and to predict who might be at higher risk of future problems like another fainting spell or needing hospital care. By doing this, the study hopes to help doctors make quicker, more accurate decisions, which could lead to better outcomes for patients in the future. This is a very important step towards improving care for people who experience fainting spells.

Key takeaways

Study aims to improve diagnosis of fainting (syncope) in emergency departments.
Specifically focuses on differentiating serious heart-related fainting from other causes.
Involves patient history, doctor's assessment, and new blood tests.
Participants must be over 40 and have fainted within the last 12 hours.
Follow-up is done by phone for two years to track long-term health.

Who may be eligible?

This study is looking for adults who have recently fainted and gone to the emergency department. To take part, you need to be over 40 years old and your fainting episode must have happened within the last 12 hours before you arrived at the hospital.

There are some reasons why you might not be able to join. For example, if you are under 40, or if your loss of consciousness was definitely due to a known neurological problem like certain types of epilepsy, then this study might not be suitable for you. Also, you need to be able to understand the study and agree to take part by giving your written permission.

If you're unsure if you fit the criteria, it's always best to ask the study staff or your doctor, as they can explain everything in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 40 years old?
Did you faint (lose consciousness) within the last 12 hours?
Did you go to the emergency department for your fainting episode?
Are you able to agree to take part in the study and give written consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process is quite straightforward. When you arrive at the emergency department, the medical team will take your medical history, as they usually would, and perform a physical examination. You'll also have a standard heart tracing (ECG) done. Additionally, you will be asked to provide a blood sample at that time for testing.

After your initial visit to the emergency department, you won't need to come back for further appointments related to the study. Instead, the study team will contact you by phone at 6 months, 12 months, and 24 months (two years) after your fainting episode. During these phone calls, they will simply ask you about your health and if you've experienced any further fainting episodes or needed any hospital care. The total duration of your participation in the study, including these follow-up calls, will be two years.

Potential risks and benefits

Participating in this study might benefit future patients as it aims to improve how doctors diagnose and manage fainting. While there are no direct health benefits to you personally, your contribution will help medical science and could lead to better care for others. The main procedure you will undergo for the study is a blood test, which carries very minor risks, such as a small bruise or slight discomfort at the site where the blood is taken. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

Baylor College of Medicine
Verified postcode
Houston, United States
Instituto Cardiovascular de Buenos Aires
Verified postcode
Buenos Aires, Argentina
Royal Brisbane and Women's hospital
Verified postcode
Brisbane, Australia
Klinikum Nürnberg
Verified postcode
Nuremberg, Germany
Sant'Andrea Hospital
Verified postcode
Rome, Italy
Christchurch Hospital
Verified postcode
Christchurch, New Zealand
Medical University of Silesia
Verified postcode
Zabrze, Poland
Hospital del Mar
Verified postcode
Barcelona, Spain
Hospital Clinic of Barcelona
Verified postcode
Barcelona, Spain
Hospital Universitario Clínico San Carlos
Verified postcode
Madrid, Spain
Kantonsspital Baselland
Verified postcode
Liestal, Switzerland
Spital Lachen
Verified postcode
Lachen, Switzerland

Common questions

What is 'syncope'?

Syncope is the medical term for fainting, which is a temporary loss of consciousness usually due to not enough blood flow to the brain.

Will I get to know the results of my blood tests from the study?

The blood tests in this study are for research purposes, and the results are usually analysed as part of the wider study findings. They are not typically given back to individual patients.

Do I need to change my medications if I join?

No, this study does not involve taking new medications or changing your current ones. It's about how doctors diagnose fainting, not about treatment.

Is this study only for people in the UK?

This is an international study, meaning it might be conducted in various countries, including the UK.

What happens to my information after the study?

Your personal information will be kept private and anonymised. The general findings from the study will be shared with the medical community to improve care for future patients.