Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
Completed
Conditions studied: Coronary Artery Bypass
In brief
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.
Key facts
- Study ID
- NCT02385344
- Run by
- Medistim ASA
- People needed
- 1046
- Starts
- 2015-04-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-09-07
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Veterans Affairs Medical Center — Washington DC, Maryland, United States
- Mount Sinai Beth Israel — New York, New York, United States
- University of Calgary — Calgary, Alberta, Canada
- University of Duisburg-Essen, Dept. of Cardiothoracic Surgery — Essen, Germany
- Clinica Cardiochirurgica — Chieti, Italy
- Erasmus University Medical Center — Rotterdam, Netherlands
- University of Oxford — Oxford, United Kingdom
Full record on ClinicalTrials.gov
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