Health TrialsbyHealthPanel

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

ConditionSyncope
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-110
SponsorUniversity of Calgary

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

  • 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.

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: All eligible participantsExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
within 2 years

Secondary outcomes

1

cost from the perspective of the health care system

Time frame
Within 2 years
2

psychometric quality of life

Time frame
Within 2 years
3

sex and gender, and patient preferences.

Time frame
Within 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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