Comparing tilt tests and ECG recordings for diagnosing unexplained fainting in older adults
Syncope Trial to Understand Tilt Testing or ECG Recording. Tenth Prevention of Syncope
NA · University of Calgary · NCT05776810
This study is testing whether doing a tilt test first helps doctors diagnose the cause of fainting better and faster in older adults compared to using a heart monitor first.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 50 Years to 110 Years |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05776810 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether performing a head-up tilt (HUT) test first in older patients with unexplained syncope leads to quicker and more accurate diagnoses compared to using an implantable loop recorder (ICM) first. A total of 144 patients aged 50 and older, who have experienced at least one fainting spell in the past year without a clear diagnosis, will be randomly assigned to one of the two diagnostic approaches. The primary goal is to establish a documented cause of syncope, with the study designed to reflect real-world clinical practices. This pragmatic trial will follow usual care protocols while assessing the effectiveness of each diagnostic strategy.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older who have experienced at least one fainting episode in the past year with no clear diagnosis.
Not a fit: Patients with known causes of syncope or significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses for older patients experiencing unexplained syncope.
How similar studies have performed: While similar diagnostic approaches have been explored, this specific comparison of HUT versus ICM in older adults is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>50 years old * ≥1 syncope26 in the prior 12 months * diagnosis unclear after history, physical exam, and electrocardiogram * no apparent risk of death due to the cause of syncope Exclusion Criteria: * cannot provide informed consent or attend routine follow up * have known left ventricular ejection fraction \< 50%,or have * pacemaker, ICD, or ICM * Class I indication for permanent pacing or ICD implantation * hypertrophic cardiomyopathy * a history of myocardial infarction within 3 months prior to enrolment * a major chronic co-morbid medical condition that would preclude 12 months of follow-up * bifascicular block * epilepsy proven by electroencephalography * syncope of known cause
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Syncope