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

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ClinicalTrials.gov Identifier: NCT04016363
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Amir Abbas Mahabadi, University Hospital, Essen

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

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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 : September 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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




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



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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

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): NCT04016363


Locations
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Germany
University Hospital Essen Not yet recruiting
Essen, NRW, Germany, 45147
Contact: Amir A Mahabadi, MD    +4920172384822    amir-abbas.mahabadi@uk-essen.de   
Sponsors and Collaborators
Amir Abbas Mahabadi

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Responsible Party: Amir Abbas Mahabadi, Principal Investigator, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04016363     History of Changes
Other Study ID Numbers: 19-TEMP815870-BO
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases