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

Coronary Artery Disease Clinical Trial

Official title:

Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04016363
• Other study ID #: 19-TEMP815870-BO
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• ProbeFix
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
• Manual hold
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Amir Abbas Mahabadi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix	During the examination
Primary	Duration of stress-echocardiography examination	Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion	During the examination
Secondary	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	During the examination