RecruitingNot ApplicableNCT05776810

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

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

Sponsor

University of Calgary

Enrollment

144 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Syncope

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

Min Age: 50 YearsMax Age: 110 Years

Inclusion Criteria4

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 Criteria10

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

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Interventions

DIAGNOSTIC_TESTDiagnostic 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 \[protocol: supine pre-tilt phase 5 min, un-medicated HUT to 70 degrees for 20 minutes; if response negative then 400 μg of sublingual nitroglycerin and continued 70 degree tilt for 20 minutes\]

DEVICEDevice: 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.