Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05776810

Conditions

Syncope

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Diagnostic Test: Head Up Tilt Table (HUT)

Device: Implantable Loop Recorder

Study Details

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

Study ID

NCT05776810

Start date

May 1, 2023

Status verified date

May, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

144 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: All eligible participants

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

Interventions

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.

Primary outcome measure

  • The primary outcome will be the determination of the diagnosis of the cause of syncope (PRECIS2 criterion 8, 5/5) within 2 years. [ Time Frame: within 2 years ]

Central Contacts and Locations

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Dr. Robert S Sheldon, MD, PhD

403-220-8191sheldon@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Dec 19, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-12-19.