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

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.

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Key information

Conditions

Coronary Artery Bypass

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medistim device

Device

This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge

Primary outcomes

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

Secondary outcomes

Record number of revisions

Time frame: Day 1 (During surgery)

Record how many Cardiac bypass patients experience intraoperative graft revision, the type of revision, and the key identifier motivating the revision
Record number of events

Time frame: Day 1-14 (During hospitalization)

Record post-surgical major adverse cardiac and cerebral events (MACCE) of all bypass procedure patients entered into the registry and occuring prior to discharge
Incidence rate

Time frame: 2 years (Throughout the study)

To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry

Sponsors and collaborators

Lead sponsor

Medistim ASA

Industry

Registry information

Acronym: REQUEST

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Mar 11, 2015
Registry last updated: Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed