Back to resultsImpact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations
Primary Purpose
Coronary Artery Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ProbeFix
Manual hold
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing clinically indicated pharmacological stress-echocardiography
- Willingness to participate
Exclusion Criteria:
- Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
- poor image quality
- Early termination of the stress-echocardiography examination for clinical reasons
Sites / Locations
- University Hospital Essen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ProbeFix arm
Controll arm
Arm Description
The echocardiography probe is fixated on the patient's thorax using the ProbeFix
The sonographer manually holds the probe on the patient's thorax
Outcomes
Primary Outcome Measures
Duration of stress-echocardiography examination
Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion
Secondary Outcome Measures
Echocardiography axis deviation in 4 chamber view
In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04016363
Brief Title
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations
Official Title
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Industrial partner was not able to provide funding
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amir Abbas Mahabadi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProbeFix arm
Arm Type
Experimental
Arm Description
The echocardiography probe is fixated on the patient's thorax using the ProbeFix
Arm Title
Controll arm
Arm Type
Active Comparator
Arm Description
The sonographer manually holds the probe on the patient's thorax
Intervention Type
Other
Intervention Name(s)
ProbeFix
Intervention Description
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
Intervention Type
Other
Intervention Name(s)
Manual hold
Intervention Description
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
Primary Outcome Measure Information:
Title
Duration of stress-echocardiography examination
Description
Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion
Time Frame
During the examination
Secondary Outcome Measure Information:
Title
Echocardiography axis deviation in 4 chamber view
Description
In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed
Time Frame
During the examination
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness
Description
Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix
Time Frame
During the examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing clinically indicated pharmacological stress-echocardiography
Willingness to participate
Exclusion Criteria:
Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
poor image quality
Early termination of the stress-echocardiography examination for clinical reasons
Facility Information:
Facility Name
University Hospital Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations
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