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Data Collection - Of Syncope Tilt Table Testing Study (COST3)

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ClinicalTrials.gov Identifier: NCT03721393
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:

To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.

To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.


Condition or disease Intervention/treatment
Orthostatic Hypotension Reflex Syncope Device: Wearable heart monitor

Detailed Description:

This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.

A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection - Of Syncope Tilt Table Testing Study
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1: Syncope patients
Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope.
 Device: Wearable heart monitor
Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment.
Group 2: Control patients
Patients that have undergone an ARS assessment and are control subjects.
 Device: Wearable heart monitor
Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Physiologic Signal Detection [ Time Frame: 12 months ]
    Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have previously undergone a ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects.
Criteria

Inclusion Criteria:

  • Willing and capable to provide informed consent
  • Age 18 or above
  • No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)
  • Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.
  • Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)

Exclusion Criteria:

  • Currently enrolled in another clinical trial that might interfere with data collection.
  • Subject is pregnant or planning to become pregnant during the study
  • Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
  • Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
  • Known allergy to materials used in the study (adhesive, ECG electrodes)
  • Diagnosed with syncope due to cardiologic causes.
  • Have had a myocardial infarction in the previous 90 days
  • Have been diagnosed with tachycardia that requires medical treatment
  • Experienced complications during previous clinically indicated ARS assessment
  • Are on medications that could affect autonomic function, if considered not safe or unwilling to hold such medications for at least four half-lives prior to testing (judged by the study Principal Investigator)
  • Have any contraindication for tilt test, Valsalva maneuver test or deep breathing test
Contacts and Locations
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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): NCT03721393


Contacts
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Contact: Ashley M Jensen, MS 651.582.4908 ashley.jensen@bsci.com
Contact: Stephen Ruble, PhD 651.582.4397 stephen.ruble@bsci.com

Locations
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United States, Minnesota
Mayo Clinic Foundation Recruiting
Rochester, Minnesota, United States, 55905
Contact: Wolfgang Singer, MD    507-284-3375    singer.wolfgang@mayo.edu   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Wolfgang Singer, MD Mayo Clinic
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03721393    
Other Study ID Numbers: C2109
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: March 2023
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: No
Keywords provided by Boston Scientific Corporation:
tilt table test, valsalva
Additional relevant MeSH terms:
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Syncope
Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Unconsciousness
Consciousness Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases