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Syncope Trial to Understand Tilt Testing Early or Recorders Study (STUTTER)

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ClinicalTrials.gov Identifier: NCT03974412
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Roopinder Sandhu, University of Alberta

Brief Summary:
Pragmatic research study to determine which of the two standard syncope therapies yields a faster path to diagnosis- head up tilt (HUT) table or implantable loop recorder (ILR).

Condition or disease Intervention/treatment Phase
Syncope Diagnostic Test: Diagnostic Test: This will be a formal pragmatic study of 2 diagnostic strategies Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Syncope Trial to Understand Tilt Testing Early or Recorders Study
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Active Comparator: Head Up Tilt Table (HUT)
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]
Diagnostic Test: Diagnostic Test: This will be a formal pragmatic study of 2 diagnostic strategies
In syncope patients at least 50 years of age, a strategy of first conducting a tilt table (HUT) will provide an earlier diagnosis at less cost than a strategy of first implanting an implantable loop recorder (ILR).

Active Comparator: 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.
Diagnostic Test: Diagnostic Test: This will be a formal pragmatic study of 2 diagnostic strategies
In syncope patients at least 50 years of age, a strategy of first conducting a tilt table (HUT) will provide an earlier diagnosis at less cost than a strategy of first implanting an implantable loop recorder (ILR).




Primary Outcome Measures :
  1. Time to diagnosis [ Time Frame: 1 year ]
    the proportion of patients with a definite diagnosis by 1 year.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(i) > 50 years old (ii) syncope (defined in 2017 ACC/AHA/HRS guidelines[16]) in the prior 12 months (iii) diagnosis unclear after history, physical exam and electrocardiogram (iv) no apparent risk of death due to the cause of syncope.

Exclusion Criteria:

(i) inability to give informed consent (ii) unable to attend routine follow up in device clinic (iii) positive carotid sinus massage.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974412


Contacts
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Contact: Roopinder Sandhu, MD 7804078594 rsandhu2@ualberta.ca
Contact: Robert Sheldon, MD 4032208191 sheldon@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Shahana Safdar, PhD    4032208897    ssafdar@ucalgary.ca   
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Xenia Cravetchi, MSc    7804078594      
Sponsors and Collaborators
University of Alberta

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Responsible Party: Roopinder Sandhu, Dr., University of Alberta
ClinicalTrials.gov Identifier: NCT03974412     History of Changes
Other Study ID Numbers: Pro00087832
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Roopinder Sandhu, University of Alberta:
syncope
head-up tilt table
implantable loop recorder
pragmatic

Additional relevant MeSH terms:
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Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms