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Syncope Trial to Understand Tilt Testing or ECG Recording Tenth Prevention of Syncope Trial ((POST10))

Primary Purpose

Syncope

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diagnostic Test: Head Up Tilt Table (HUT)
Device: Implantable Loop Recorder
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope

Eligibility Criteria

50 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All eligible participants

Arm Description

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

Outcomes

Primary Outcome Measures

The primary outcome will be the determination of the diagnosis of the cause of syncope (PRECIS2 criterion 8, 5/5) within 2 years.

Secondary Outcome Measures

cost from the perspective of the health care system
psychometric quality of life
sex and gender, and patient preferences.

Full Information

First Posted
March 1, 2023
Last Updated
March 17, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05776810
Brief Title
Syncope Trial to Understand Tilt Testing or ECG Recording Tenth Prevention of Syncope Trial
Acronym
(POST10)
Official Title
Syncope Trial to Understand Tilt Testing or ECG Recording. Tenth Prevention of Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All eligible participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic Test: Head Up Tilt Table (HUT)
Intervention Description
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]
Intervention Type
Device
Intervention Name(s)
Device: Implantable Loop Recorder
Intervention Description
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 Information:
Title
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
Secondary Outcome Measure Information:
Title
cost from the perspective of the health care system
Time Frame
Within 2 years
Title
psychometric quality of life
Time Frame
Within 2 years
Title
sex and gender, and patient preferences.
Time Frame
Within 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Robert S Sheldon, MD, PhD
Phone
403-220-8191
Email
sheldon@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Dr. Robert S Sheldon, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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