Coronary Artery BypassREQUESTNCT02385344
Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
An observational study of Coronary Artery Bypass, run by Medistim ASA at 7 sites in 6 countries.
Trial summary
The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Medistim device
- Type of treatment
- Medical device
- How many people
- 1,046 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Apr 2015to Dec 2017
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subject has been scheduled for coronary bypass surgery
Who may be able to join
- Subject has been scheduled for coronary bypass surgery
- Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure
- Subject has been diagnosed with 2-3 vessel disease
Who cannot join
- Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.)
- Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing
- Subject is undergoing an emergency cardiac bypass surgery
- Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation > 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction)
- Subject has any condition that the investigator believes should exclude him/her from this registry
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United States2 sites
Mount Sinai Beth Israel
New York, New York, 10003
Veterans Affairs Medical Center
Washington DC, Maryland, 20422
Germany1 site
University of Duisburg-Essen, Dept. of Cardiothoracic Surgery
Essen, 45122
About this study
The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.
- Conditions
- Coronary Artery Bypass
- Being tested
- Medistim device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medistim deviceDevice
This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in planned surgical procedure
Identify how often epiaortic scanning With the Medistim Device, leads to a change in the planned surgical procedure and to identify the reason and the procedure change
Measured: Day 1 (During Surgery)
Procedure adaptions
Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function
Measured: Day 1 (During surgery)
Secondary outcomes (3)
Record number of revisions
Record how many Cardiac bypass patients experience intraoperative graft revision, the type of revision, and the key identifier motivating the revision
Measured: Day 1 (During surgery)
Record number of events
Record post-surgical major adverse cardiac and cerebral events (MACCE) of all bypass procedure patients entered into the registry and occuring prior to discharge
Measured: Day 1-14 (During hospitalization)
Incidence rate
To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry
Measured: 2 years (Throughout the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies 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
- 1,046 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Medistim ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Waaler, MSc Pharm, Study director, Medistim ASA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385344
- Sponsor's protocol ID
- 1501
- Acronym
- REQUEST
- Status last verified
- Sep 2018
- First submitted
- 17 Feb 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Leviner DB, von Mucke Similon M, Rosati CM, Amabile A, Thuijs DJFM, Giammarco GD, Wendt D, Trachiotis GD, Kieser TM, Kappetein AP, Head SJ, Taggart DP, Puskas JD. Transit time flow measurement of coronary bypass grafts before and after protamine administration. J Cardiothorac Surg. 2021 Jul 9;16(1):195. doi: 10.1186/s13019-021-01575-y.
PubMed 34243799Rosenfeld ES, Trachiotis GD, Napolitano MA, Sparks AD, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative transit-time flow measurement and high-frequency ultrasound in coronary artery bypass grafting: impact in off versus on-pump, arterial versus venous grafting and cardiac territory grafted. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):204-213. doi: 10.1093/ejcts/ezab239.
PubMed 34166508Rosenfeld ES, Trachiotis GD, Sparks AD, Napolitano MA, Lee KB, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative surgical strategy changes in patients with chronic and end-stage renal disease undergoing coronary artery bypass grafting. Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1210-1217. doi: 10.1093/ejcts/ezab104.
PubMed 33675642
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
- ClinicalTrials.gov ID
- NCT02385344
- Acronym / sponsor ID
- REQUEST / 1501
- Conditions
- Coronary Artery Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,046 participants (actual)
- Lead sponsor
- Medistim ASAIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Mar 2015 (estimated)
- 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.
The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subject has been scheduled for coronary bypass surgery
Key inclusion criteria (3 listed)
- Subject has been scheduled for coronary bypass surgery
- Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure
- Subject has been diagnosed with 2-3 vessel disease
Key exclusion criteria (5 listed)
- Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.)
- Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing
- Subject is undergoing an emergency cardiac bypass surgery
- Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation > 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction)
- Subject has any condition that the investigator believes should exclude him/her from this registry
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 |
|---|---|---|
| Medistim deviceThis registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge | Device | – |
Primary outcome
Change in planned surgical procedure
Time frame: Day 1 (During Surgery)
Identify how often epiaortic scanning With the Medistim Device, leads to a change in the planned surgical procedure and to identify the reason and the procedure change
Procedure adaptions
Time frame: Day 1 (During surgery)
Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function
3 secondary outcomes
Record number of revisions
Time frame: Day 1 (During surgery)
Record number of events
Time frame: Day 1-14 (During hospitalization)
Incidence rate
Time frame: 2 years (Throughout the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 34243799Leviner DB, von Mucke Similon M, Rosati CM, Amabile A, Thuijs DJFM, Giammarco GD, Wendt D, Trachiotis GD, Kieser TM, Kappetein AP, Head SJ, Taggart DP, Puskas JD. Transit time flow measurement of coronary bypass grafts before and after protamine administration. J Cardiothorac Surg. 2021 Jul 9;16(1):195. doi: 10.1186/s13019-021-01575-y.
- Derived from this study: PubMed 34166508Rosenfeld ES, Trachiotis GD, Napolitano MA, Sparks AD, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative transit-time flow measurement and high-frequency ultrasound in coronary artery bypass grafting: impact in off versus on-pump, arterial versus venous grafting and cardiac territory grafted. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):204-213. doi: 10.1093/ejcts/ezab239.
- Derived from this study: PubMed 33675642Rosenfeld ES, Trachiotis GD, Sparks AD, Napolitano MA, Lee KB, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative surgical strategy changes in patients with chronic and end-stage renal disease undergoing coronary artery bypass grafting. Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1210-1217. doi: 10.1093/ejcts/ezab104.
Related trials for Coronary Artery Bypass
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RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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Thiamine Intervention and Coronary Artery Bypass Grafting
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Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
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Coronary Artery Bypass Graft (CABG)
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.
Anne Waaler, MSc Pharm study director
Medistim ASA
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass, run by Medistim ASA at 7 sites in 6 countries.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Germany, Italy, Netherlands and 1 more country. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in planned surgical procedure (time frame: Day 1 (During Surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02385344, which also lists 3 linked publications.
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 7 Sep 2018.