Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Other: ProbeFix Other: Manual hold | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study |
Estimated Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | December 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Experimental: ProbeFix arm
The echocardiography probe is fixated on the patient's thorax using the ProbeFix
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Other: ProbeFix
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
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Active Comparator: Controll arm
The sonographer manually holds the probe on the patient's thorax
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Other: Manual hold
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
University Hospital Essen | |
Essen, NRW, Germany, 45147 | |
Contact: Amir A Mahabadi, MD +4920172384822 amir-abbas.mahabadi@uk-essen.de |
Tracking Information | |||||
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First Submitted Date ICMJE | July 8, 2019 | ||||
First Posted Date ICMJE | July 11, 2019 | ||||
Last Update Posted Date | September 26, 2019 | ||||
Estimated Study Start Date ICMJE | January 1, 2020 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Duration of stress-echocardiography examination [ Time Frame: During the examination ] Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Echocardiography axis deviation in 4 chamber view [ Time Frame: During the examination ] In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Cost-effectiveness [ Time Frame: During the examination ] Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations | ||||
Official Title ICMJE | Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Coronary Artery Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
72 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Germany | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04016363 | ||||
Other Study ID Numbers ICMJE | 19-TEMP815870-BO | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Amir Abbas Mahabadi, University Hospital, Essen | ||||
Study Sponsor ICMJE | Amir Abbas Mahabadi | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University Hospital, Essen | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |