Diagnostic Tests for Fainting

((POST10) Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Pacemaker, ICD, Hypertrophic cardiomyopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

Trial Summary

What is the purpose of this trial?

The Study To Understand Tilt Tests versus Extended Recordings (STUTTER, POST 10) will test the hypothesis that first performing a diagnostic HUT in older patients with syncope of unknown cause will provide earlier and more diagnoses than inserting an ICM.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the implantable loop recorder (ILR) safe for humans?

The implantable loop recorder (ILR) is considered safe and easy to use, which has led to its widespread use in various hospitals for diagnosing fainting and palpitations. ^{1 2 3 4 5}

How is the implantable loop recorder treatment different from other treatments for fainting?

The implantable loop recorder (ILR) is unique because it continuously monitors heart rhythms over a long period, helping to diagnose fainting episodes when the cause is unclear, unlike other tests that provide only a snapshot in time. This makes it particularly useful for identifying heart-related causes of fainting that might not be detected with standard tests. ^{3 6 7 8 9}

Eligibility Criteria

This trial is for people over 50 who've fainted at least once in the past year and don't know why, even after a check-up and heart tracing. They should be generally healthy enough to participate for a year. It's not for those with certain heart conditions, epilepsy, recent heart attacks, or existing pacemakers.

Inclusion Criteria

You are not at risk of dying from fainting.

I have fainted at least once in the last year.

My diagnosis is still unclear after basic tests.

Exclusion Criteria

You have been diagnosed with epilepsy using a test called electroencephalography.

You have a condition called bifascicular block.

I need a pacemaker or an ICD as recommended by my doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo either a Head-Up Tilt Table procedure or receive an Implantable Loop Recorder to diagnose the cause of syncope

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing

12 weeks

Treatment Details

Interventions

• Device: Implantable Loop Recorder
• Diagnostic Test: Head Up Tilt Table (HUT)

Trial Overview The study compares two methods to diagnose unexplained fainting in older adults: a tilt table test that checks how your body responds to changes in position versus an implantable device that continuously records your heart's activity.

Participant Groups

Group I: All eligible participants Experimental Treatment 2 Interventions

All eligible participants are randomly assigned to one of two interventions- early Head-Up Tilt Table procedure or early Implantable Loop Recorder. The assignment is random and at a 1:1 ratio between the two strategies. Interventions: Diagnostic Test: Head Up Tilt Table (HUT) Device: Implantable Loop Recorder

Device: Implantable Loop Recorder is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Approved in United States as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Approved in Canada as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Approved in Japan as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

The Reveal Plus insertable loop recorder (ILR) is effective for diagnosing cardiac arrhythmias in patients with unexplained fainting (syncope), providing a high diagnostic yield.

The device is easy to insert and has been associated with improved patient outcomes, highlighting the importance for medical-surgical nurses to understand its use and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the insertable loop recorder to detect cardiac arrhythmias during syncopal episodes. Reiff, PA., Gutierrez, JD.[2007]

In a study of 27 pediatric patients with infrequent syncope or palpitations, the Reveal insertable loop recorder (ILR) proved to be highly diagnostic, identifying issues in 95% of cases, primarily bradyarrhythmias like pauses and intermittent AV block.

The ILR was effective in guiding treatment decisions, leading to pacemaker implantation in five patients, while no life-threatening events were detected, highlighting its safety and utility in managing pediatric cardiac symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How revealing are insertable loop recorders in pediatrics? Frangini, PA., Cecchin, F., Jordao, L., et al.[2022]

The study involved 214 patients with recurrent unexplained syncope and compared three tilt testing protocols, finding that the GTN protocol led to significantly more diagnoses (47% overall diagnosis rate) than the other methods.

The GTN protocol demonstrated good sensitivity (50%) and high specificity (100%), while the drug-free protocol had lower sensitivity (21%), indicating that drug-augmented tilt testing is more effective for diagnosing syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised prospective comparison of three protocols for head-up tilt testing and carotid sinus massage. Farwell, DJ., Sulke, AN.[2009]

In a study of 743 patients with implantable loop recorders (ILRs), those in secondary hospitals had a higher final diagnosis rate (55.4%) compared to those in tertiary hospitals (30.8%), despite similar clinical characteristics.

While tertiary hospitals conducted more electrophysiologic studies and tilt table tests, the safety profile was comparable between both groups, with no significant differences in rates of deaths or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the yield of the implantable loop recorder between secondary and tertiary centers. Lacunza-Ruiz, FJ., Moya-Mitjans, A., Martínez-Alday, J., et al.[2015]

In a study of 547 patients with syncope at a Japanese medical center, the most common causes identified were cardiac syncope (34.0%) and reflex syncope (29.1%), highlighting the diverse origins of syncope in this population.

The use of implantable loop recorders (ILRs) significantly improved diagnostic rates for unexplained syncope, achieving 47% and 65% diagnostic rates at 1 and 2 years post-implantation, respectively, compared to conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single center experience in Japanese patients with syncope. Onuki, T., Ito, H., Ochi, A., et al.[2018]

The implantable loop recorder successfully diagnosed the cause of syncope in 60% of patients (15 out of 25) who had previously undergone extensive testing without a clear diagnosis.

During an average monitoring period of 13 months, the loop recorder detected significant arrhythmias in 40% of patients, including bradyarrhythmias and tachyarrhythmias, highlighting its efficacy in identifying underlying cardiac issues related to syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic benefit of the use of implanted loop recorder (Reveal Plus) for patients with syncope with unclear aetiology]. Mitro, P., Szakács, M., Bodnár, J., et al.[2014]

In a study of 48 patients with unexplained syncope, the use of an implantable loop recorder (ILR) successfully identified arrhythmias in 88% of those who experienced recurrent syncope, demonstrating its effectiveness in diagnosing the underlying causes of syncope.

The findings from the ILR led to significant clinical interventions, including the implantation of 12 pacemakers and 2 radiofrequency ablations, highlighting its impact on treatment decisions for patients with unexplained syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic yield of the implantable loop recorder to detect the mechanism of syncope--a single center long term experience of a tertiary care center]. Brunckhorst, CB., Lemola, K., Holzmeister, J., et al.[2019]

Tilt table tests are valuable for diagnosing neurally mediated syncope but have notable limitations that must be considered.

Implantable loop recorders have been shown to be safe and effective in diagnosing syncope, particularly in older patients, and can help identify those who may benefit from permanent pacing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tilt table testing and implantable loop recorders for syncope. Sheldon, R.[2012]

The Reveal implantable loop recorder (ILR) was effective in diagnosing the cause of unexplained recurrent syncope, providing a diagnosis in 78% of cases, primarily identifying cardiac issues.

In a study involving 570 patients over an average follow-up of 10 months, the ILR demonstrated a significant advantage over traditional diagnostic tests, supporting its early use in clinical practice for unexplained syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Edvardsson, N., Frykman, V., van Mechelen, R., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of the insertable loop recorder to detect cardiac arrhythmias during syncopal episodes. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

How revealing are insertable loop recorders in pediatrics? [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A randomised prospective comparison of three protocols for head-up tilt testing and carotid sinus massage. [2009]

4. Poland pubmed.ncbi.nlm.nih.gov

Differences in the yield of the implantable loop recorder between secondary and tertiary centers. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Single center experience in Japanese patients with syncope. [2018]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Diagnostic benefit of the use of implanted loop recorder (Reveal Plus) for patients with syncope with unclear aetiology]. [2014]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Diagnostic yield of the implantable loop recorder to detect the mechanism of syncope--a single center long term experience of a tertiary care center]. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Tilt table testing and implantable loop recorders for syncope. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. [2021]