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

Completed

• Conditions: Coronary Artery Bypass

• Registration Number: NCT02385344
• Lead Sponsor: Medistim ASA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Study Start: 2015-04
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1046

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in planned surgical procedure	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	Day 1 (During surgery)	Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function

Secondary Outcome Measures

Name	Time	Method
Record number of revisions	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	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	2 years (Throughout the study)	To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry

Trial Locations

Locations (7)

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States

University of Oxford; 🇬🇧 Oxford, United Kingdom

Clinica Cardiochirurgica; 🇮🇹 Chieti, Italy

Veterans Affairs Medical Center; 🇺🇸 Washington DC, Maryland, United States

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Duisburg-Essen, Dept. of Cardiothoracic Surgery; 🇩🇪 Essen, Germany