Coronary Artery DiseaseNCT04016363
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations
A study testing ProbeFix and Manual hold in people with Coronary Artery Disease, run by Amir Abbas Mahabadi at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ProbeFix and Manual hold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing clinically indicated pharmacological stress-echocardiography
- Willingness to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study
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
- Being tested
- ProbeFix, Manual hold
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbeFixOther
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
Manual holdOther
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
| Study group | Role | What they receive |
|---|---|---|
| ProbeFix arm | Experimental | The echocardiography probe is fixated on the patient's thorax using the ProbeFix Receives: Other: ProbeFix |
| Controll arm | Active comparator | The sonographer manually holds the probe on the patient's thorax Receives: Other: Manual hold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of stress-echocardiography examination
Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion
Measured: During the examination
Secondary outcomes (1)
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
Measured: During the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jan 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Industrial partner was not able to provide funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amir Abbas Mahabadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amir Abbas Mahabadi, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016363
- Sponsor's protocol ID
- 19-TEMP815870-BO
- Status last verified
- Oct 2021
- First submitted
- 8 Jul 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study
- ClinicalTrials.gov ID
- NCT04016363
- Acronym / sponsor ID
- 19-TEMP815870-BO
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Industrial partner was not able to provide funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Amir Abbas MahabadiUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProbeFix arm | Experimental | Other: ProbeFixThe echocardiography probe is fixated on the patient's thorax using the ProbeFix |
| Controll arm | Active comparator | Other: Manual holdThe sonographer manually holds the probe on the patient's thorax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing clinically indicated pharmacological stress-echocardiography
- Willingness to participate
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbeFixProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations | Other | ProbeFix arm |
| Manual holdProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations | Other | Controll arm |
Primary outcome
Duration of stress-echocardiography examination
Time frame: During the examination
Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion
1 secondary outcome
Echocardiography axis deviation in 4 chamber view
Time frame: During the examination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProbeFix and Manual hold in people with Coronary Artery Disease, run by Amir Abbas Mahabadi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of stress-echocardiography examination (time frame: During the examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.