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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Medistim ASA
Sponsor:
Information provided by (Responsible Party):
Medistim ASA
ClinicalTrials.gov Identifier:
NCT02385344
First received: February 17, 2015
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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 Intervention
Coronary Artery Bypass Device: Medistim device

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medistim ASA:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: April 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Medistim device
    This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge
  Eligibility

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02385344

Contacts
Contact: Tone Veiteberg, MSc Pharm +47 400 66660 tone.veiteberg@medistim.com

Locations
United States, Maryland
Veterans Affairs Medical Center Recruiting
Washington DC, Maryland, United States, 20422
Contact: Gregory D Trachiotis, MD         
United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: John D Puskas, MD         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, AB T2N 1N4
Contact: Teresa M Kieser, MD         
Germany
University of Duisburg-Essen, Dept. of Cardiothoracic Surgery Recruiting
Essen, Germany, 45122
Contact: Daniel Wendt, PD         
Italy
Clinica Cardiochirurgica Recruiting
Via dei Vestini, Chieti, Italy, 66100
Contact: Gabriele Di Giammarco, MD         
Netherlands
Erasmus University Medical Center Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Pieter Kappetein, PHD         
United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: David P Taggart, PHD         
Sponsors and Collaborators
Medistim ASA
Investigators
Study Director: Anne Waaler, MSc Pharm Medistim ASA
  More Information

Responsible Party: Medistim ASA
ClinicalTrials.gov Identifier: NCT02385344     History of Changes
Other Study ID Numbers: 1501
Study First Received: February 17, 2015
Last Updated: May 12, 2017

ClinicalTrials.gov processed this record on August 16, 2017