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出境医 / 临床实验 / Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: ProbeFix Other: Manual hold Not Applicable

Study Design
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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
Arms and Interventions
Arm Intervention/treatment
Experimental: ProbeFix arm
The echocardiography probe is fixated on the patient's thorax using the ProbeFix
Other: ProbeFix
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Active Comparator: Controll arm
The sonographer manually holds the probe on the patient's thorax
Other: Manual hold
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Outcome Measures
Primary Outcome Measures :
  1. Duration of stress-echocardiography examination [ Time Frame: During the examination ]
    Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Cost-effectiveness [ Time Frame: During the examination ]
    Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix


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
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
Contacts and Locations

Locations
Layout table for location information
Germany
University Hospital Essen
Essen, NRW, Germany, 45147
Contact: Amir A Mahabadi, MD    +4920172384822    amir-abbas.mahabadi@uk-essen.de   
Sponsors and Collaborators
Amir Abbas Mahabadi
Tracking Information
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
 (submitted: July 8, 2019)
Duration of stress-echocardiography examination [ Time Frame: During the examination ]
Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2019)
Cost-effectiveness [ Time Frame: During the examination ]
Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix
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
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Other: ProbeFix
    ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
  • Other: Manual hold
    ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
Study Arms  ICMJE
  • Experimental: ProbeFix arm
    The echocardiography probe is fixated on the patient's thorax using the ProbeFix
    Intervention: Other: ProbeFix
  • Active Comparator: Controll arm
    The sonographer manually holds the probe on the patient's thorax
    Intervention: Other: Manual hold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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

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