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

NCT04016363 | Withdrawn

• 1 other identifier: 19-TEMP815870-BO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Duration of stress-echocardiography examination

  Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion

  During the examination

Secondary Outcomes (1)

• Echocardiography axis deviation in 4 chamber view

  During the examination

Other Outcomes (1)

• Cost-effectiveness

  During the examination

Study Arms (2)

ProbeFix arm

EXPERIMENTAL

The echocardiography probe is fixated on the patient's thorax using the ProbeFix

Other: ProbeFix

Controll arm

ACTIVE COMPARATOR

The sonographer manually holds the probe on the patient's thorax

Other: Manual hold

Interventions

ProbeFix OTHER

ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

ProbeFix arm

Manual hold OTHER

ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Controll arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing clinically indicated pharmacological stress-echocardiography
• Willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Amir Abbas Mahabadi: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: January 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

DE (1)