Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05776810 |
| Other study ID # |
POST 10 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University of Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
A total of 144 patients ≥50 years old with ≥1 syncopal spell in the preceding year who lack a
clear etiologic diagnosis for syncope and no clinically apparent structural heart disease
will be randomized to first undergo HUT or to first receive an ICM in an open label, parallel
group study. The primary outcome measure will be the establishment of a documented etiologic
diagnosis of the cause of syncope, defined below. This will be a formal pragmatic study of
two diagnostic strategies, designed around the PRECIS2 criteria. The key question addresses
which test should be done first, and beyond that care will be left in the hands of the
specialist physician with primary responsibility for assessing and managing syncope.
This is a Pragmatic Trial, which is a rigorous randomized trial method that enables the study
of interventions in the real world. Pragmatic trials are designed to determine the effects of
an intervention under the usual conditions in which it will be applied, in contrast to
conventional explanatory biomedical trials that are designed to determine the effects of an
intervention under ideal circumstances. The researcher's touchstone is usual syncope
specialist management. There are 9 criteria of the PRECIS2 tool for pragmatic trials:1)
similarity of eligibility criteria to usual care, 2) no extra recruitment effort, 3) similar
setting to usual care, 4) similar health care organization and delivery to usual care, 5)
similar flexibility to usual care, 6) similar flexibility in patient monitoring, 7) similar
follow-up intensity to usual care, 8) direct relevance of primary outcome to participants,
and 9) completeness of data inclusion. Each criterion is scored 1-5; the researchers provide
these scores for each criterion. Study design and conduct are designed to resemble real
clinical practice with its variable conduct and decision-making. The primary outcome is
establishing a diagnosis by one of two recommended methods, and both methods have
evidence-based criteria. the researchers will issue a brochure to remind investigators of the
guidelines' criteria. Both have objective ECG criteria and tilt tests have BP criteria. Bias
is a concern, and the Outcomes Adjudication Committee will adjudicate post hoc all results
blindly.
