Clinical trial NCT02385344: Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
Official title: Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass
Lead sponsor: Medistim ASA
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 1046
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject has been scheduled for coronary bypass surgery

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in planned surgical procedure
timeFrame: Day 1 (During Surgery)
measure: Procedure adaptions
timeFrame: Day 1 (During surgery)
Secondary outcomes:
measure: Record number of revisions
timeFrame: Day 1 (During surgery)
measure: Record number of events
timeFrame: Day 1-14 (During hospitalization)
measure: Incidence rate
timeFrame: 2 years (Throughout the study)
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Veterans Affairs Medical Center
state: Maryland
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Essen
country: Germany
facility: University of Duisburg-Essen, Dept. of Cardiothoracic Surgery
city: Chieti
country: Italy
facility: Clinica Cardiochirurgica
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: Medistim ASA
name: Anne Waaler, MSc Pharm
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Rosenfeld 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.
citation: Rosenfeld 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.