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Syncope Trial to Understand Tilt Testing or ECG Recording Tenth Prevention of Syncope Trial

This research, called STUTTER, is for people over 50 who have had fainting spells (syncope) and doctors aren't sure why. It's designed to figure out the best first step to diagnose the problem. The study compares two different approaches: one group will have a 'head-up tilt table' test first, and the other group will have a tiny heart monitor (called an Implantable Loop Recorder) put under their skin first. Both tests help doctors look at how your body reacts when you faint. The main goal is to see which of these methods leads to a diagnosis faster, so people can get the right treatment sooner. It’s a practical study, meaning it tries to reflect how doctors work in real life.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Calgary
Enrolment target
144
Start
01 May 2023
Estimated completion
31 Dec 2026
Syncope

What is this study about?

When someone faints, it can be a worrying experience, and doctors often need to do tests to find out why it happened. This study, called STUTTER, focuses on people aged 50 and over who have had fainting spells (doctors call this syncope) but haven't yet found a clear reason for them after initial checks like a heart tracing (ECG). The main idea behind STUTTER is to find out the most effective way to diagnose the cause of these fainting spells.

The doctors running this study want to compare two common ways of investigating fainting. One is a 'head-up tilt table' test, where you lie on a table that's tilted upwards to see if it makes you feel faint or actually faint, while your heart rate and blood pressure are monitored. The other is to implant a small device called an 'Implantable Loop Recorder' (ILR) just under the skin in your chest. This device continuously records your heart's electrical activity over a long period, helping to catch any unusual rhythms that might cause fainting.

The study aims to see which of these two approaches, used as the *first* diagnostic step, helps doctors get a clear answer about what's causing the fainting spells more quickly. By understanding this, doctors can then decide on the best treatment for you. This is a very practical study, meaning it's designed to reflect how real-world doctors and patients experience diagnosis, rather than being in a highly controlled, artificial environment.

Key takeaways

  • Compares two ways to find the cause of fainting in people over 50.
  • Aims to see if a tilt test or an implanted heart monitor works best first.
  • Could lead to faster diagnosis and better treatment for fainting spells.
  • Participation involves being assigned to one test and having follow-up for about a year.
  • Designed to be practical, like real-world doctor visits.

Who may be eligible?

This study is looking for people who are 50 years old or older. You would need to have had at least one fainting spell (syncope) in the last year, and your doctor still shouldn't know the exact reason why you're fainting after looking at your medical history, doing a physical check, and an ECG heart tracing. Importantly, the doctors must not think that your fainting is due to a serious, immediate heart problem.

There are also some reasons why you might not be able to join. For example, if you can't give proper consent or attend regular follow-up appointments. You also can't be in the study if you already have certain heart conditions or devices, like a pacemaker, a defibrillator (ICD), or another implantable loop recorder. If you've had a heart attack in the last three months, or if you have other ongoing, severe health problems that would make it hard for you to complete a year of follow-up, you wouldn't be able to take part. Also, if the cause of your fainting is already known, or if you have certain epilepsy diagnoses, this study wouldn't be right for you.

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.

  1. Are you 50 years old or older?
  2. Have you had at least one fainting spell in the past year?
  3. Do doctors currently not know the clear cause of your fainting?
  4. Are you able to provide consent and attend appointments regularly?
  5. Do you *not* have a pacemaker, defibrillator, or already a loop recorder?
  6. Do you *not* have a serious heart condition that puts you at immediate risk?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will first have a 'head-up tilt table' test. This involves lying on a special bed that gently tilts you upright while doctors monitor your heart rate and blood pressure to see if it causes fainting. The other group will first have a small heart monitor (an Implantable Loop Recorder) placed under the skin in your chest in a minor procedure; this device then records your heart's activity for a long time.

After this initial test, your care will continue as usual, with your specialist doctor deciding on any further investigations or treatments. The study aims to see which first test leads to a diagnosis faster. You'll need to attend regular follow-up appointments, and the study will track your progress for about 12 months in total. There are no specific medications given as part of this study, as it's looking at diagnostic tests.

Potential risks and benefits

Taking part in this study could potentially help identify the cause of your fainting spells more quickly, which means you could get the right treatment sooner. There's also the benefit of helping other people in the future by improving our understanding of how to best diagnose syncope. As with any medical procedure, there are potential risks, such as discomfort from the tilt table test or minor risks associated with the implantation of the heart monitor (like a small bruise or infection). You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • University of Calgary
    Verified postcode
    Calgary, Canada· Recruiting

Common questions

What is syncope?

Syncope is the medical term for a fainting spell or a temporary loss of consciousness, often caused by a temporary drop in blood flow to the brain.

What is a head-up tilt table test?

It's a test where you lie on a special table that is gently tilted upright. Your blood pressure and heart rate are monitored to see if standing up causes you to feel faint or actually faint.

What is an Implantable Loop Recorder (ILR)?

An ILR is a very small device, about the size of a USB stick, that is placed just under the skin in your chest. It continuously records your heart's electrical activity to help catch any unusual heart rhythms that might be causing fainting.

Will I definitely get a diagnosis if I join the study?

The study aims to help doctors find a diagnosis, but like any medical investigation, there’s no absolute guarantee of finding the cause of your fainting spells. The goal is to compare two common approaches and see which one is more effective at leading to a diagnosis faster.

Do I have to take any new medication as part of this study?

No, this study is about diagnostic tests, not new medications. Your medical care for any conditions you have will continue as usual, and your doctor will decide on any treatments based on the findings.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Syncope Trial to Understand Tilt Testing or ECG Recording Te…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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