Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery (REQUEST)

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 Overview

• Status: Completed
• Conditions: Coronary Artery Bypass
• Intervention / Treatment: Device: Medistim device

• Study Type: Observational
• Enrollment (Actual): 1046

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, AB T2N 1N4
      • University of Calgary
• Germany
  • Essen, Germany, 45122
    • University of Duisburg-Essen, Dept. of Cardiothoracic Surgery
• Italy
  • Chieti, Italy, 66100
    • Clinica Cardiochirurgica
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus University Medical Center
• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • University of Oxford
• United States
  • Maryland
    • Washington DC, Maryland, United States, 20422
      • Veterans Affairs Medical Center
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject has been scheduled for coronary bypass surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 1 (During surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	2 years (Throughout the study)

Collaborators and Investigators

• Sponsor: Medistim ASA
• Investigators: Study Director: Anne Waaler, MSc Pharm, Medistim ASA

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (ESTIMATE): March 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1501 (CSL Behring)