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

NCT05776810 | Recruiting

• 1 other identifier: POST 10
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Syncope

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• cost from the perspective of the health care system

  Within 2 years

• psychometric quality of life

  Within 2 years

• sex and gender, and patient preferences.

  Within 2 years

Study Arms (1)

All eligible participants

EXPERIMENTAL

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

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

Interventions

Diagnostic Test: Head Up Tilt Table (HUT) DIAGNOSTIC_TEST

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

All eligible participants

Device: Implantable Loop Recorder DEVICE

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.

All eligible participants

Eligibility Criteria

• Age: 50 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Related Publications (1)

• Happ S, Raj SR, Chew D, Sheldon R. Physician Perspectives on the Initial Diagnostic Strategy of Syncope in Older Patients Without Diagnostic Clues. Ann Noninvasive Electrocardiol. 2026 Mar;31(2):e70155. doi: 10.1111/anec.70155.

  PMID: 41614589 DERIVED

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 20, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)