Diagnostic Test: Head Up Tilt Table (HUT)Device: Implantable Loop Recorder
Diagnostic Test: Head Up Tilt Table (HUT): Participant randomized to open-label diagnostic strategy. Results and all follow-up care to be in the hands of treating cardiologist as this is a pragmatic study.
the early HUT \[protocol: supine pre-tilt phase 5 min, un-medicated HUT to 70 degrees for 20 minutes; if response negative then 400 μg of sublingual nitroglycerin and continued 70 degree tilt for 20 minutes\]
Device: Implantable Loop Recorder: ILR is a small subcutaneously implanted device, lasting up to 3 years, that records heart rhythms, and which may be either auto-triggered or patientactivated.
Study 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
110 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The primary outcome will be the determination of the diagnosis of the cause of syncope (PRECIS2 criterion 8, 5/5) within 2 years. — within 2 years
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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