Cardiac Bypass Surgery (CABG)CASESNCT06360224
Collect Flow and Ultrasound Images of Coronary Bypass Grafts
An observational study of Cardiac Bypass Surgery (CABG), run by Medistim ASA.
Trial summary
This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Bypass Surgery (CABG)
- What is being tested?
- MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients scheduled for cardiac bypass surgery (CABG) that have signed an informed consent form for this study
Who may be able to join
- Patient older than 18 years
- Scheduled for CABG
- Understand the nature of the procedure and willingness to comply with the CIP
- Provide written informed consent
Who cannot join
- Patient younger than 18 years
- Any condition that the investigator believes should exclude participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).
- Conditions
- Cardiac Bypass Surgery (CABG)
- Being tested
- MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probesDevice
The objective of this study is to harvest a wide dataset of high quality to allow exploratory analysis and training of machine learning
What is being measured
The primary outcome is the main question the study is designed to answer.
Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion15 May 2029 (estimated)
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Bypass Surgery (CABG)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medistim ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360224
- Sponsor's protocol ID
- CASES
- Acronym
- CASES
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collect Flow and Ultrasound Images of Coronary Bypass Grafts
- ClinicalTrials.gov ID
- NCT06360224
- Acronym / sponsor ID
- CASES / CASES
- Conditions
- Cardiac Bypass Surgery (CABG)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medistim ASAIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 May 2029 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 11 Apr 2024 (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.
This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac bypass surgery (CABG) that have signed an informed consent form for this study
Key inclusion criteria (4 listed)
- Patient older than 18 years
- Scheduled for CABG
- Understand the nature of the procedure and willingness to comply with the CIP
- Provide written informed consent
Key exclusion criteria (2 listed)
- Patient younger than 18 years
- Any condition that the investigator believes should exclude participation
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 |
|---|---|---|
| MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probesThe objective of this study is to harvest a wide dataset of high quality to allow exploratory analysis and training of machine learning | Device | – |
Primary outcome
Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
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Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
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Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Bypass Surgery (CABG), run by Medistim ASA.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haakon Grøthe (04790968263, haakon.groethe@medistim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures. (time frame: 1 day). 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 11 Apr 2024.