Trial record 1 of 1 for:    NCT02385344
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Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery (REQUEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02385344
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronary Artery Bypass Device: Medistim device

Study Type : Observational [Patient Registry]
Actual Enrollment : 1044 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
Study Start Date : April 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Medistim device
    This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge

Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject has been scheduled for coronary bypass surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02385344

United States, Maryland
Veterans Affairs Medical Center
Washington DC, Maryland, United States, 20422
United States, New York
Mount Sinai Beth Israel
New York, New York, United States, 10003
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, AB T2N 1N4
University of Duisburg-Essen, Dept. of Cardiothoracic Surgery
Essen, Germany, 45122
Clinica Cardiochirurgica
Chieti, Italy, 66100
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 GD
United Kingdom
University of Oxford
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Medistim ASA
Study Director: Anne Waaler, MSc Pharm Medistim ASA

Responsible Party: Medistim ASA Identifier: NCT02385344     History of Changes
Other Study ID Numbers: 1501
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018