Coronary Flow Rate Measurement in T-Grafts
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
T-Graft
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring patients scheduled for bypass grafting
Eligibility Criteria
Inclusion Criteria:
- coronary heart disease
- Age > 18 ys
- Ejection fraction > 45%
Exclusion Criteria:
- myocardial infarction
- Re-Intervention
Sites / Locations
- Johann Wolfgang Goethe Universitätsklinikum
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
surgical procedure
Arm Description
T-graft bypass or conventional bypass
Outcomes
Primary Outcome Measures
Coronary flow reserve
Secondary Outcome Measures
Full Information
NCT ID
NCT01170988
First Posted
July 27, 2010
Last Updated
August 5, 2014
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Bethanien Krankenhaus gGmbH
1. Study Identification
Unique Protocol Identification Number
NCT01170988
Brief Title
Coronary Flow Rate Measurement in T-Grafts
Official Title
Comparison of Coronary Flow Reserve in Two Different Bypass Techniques (T-graft Technique Versus Isolated Graft Technique) Using Magnetic Resonance Technology (MRT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Bethanien Krankenhaus gGmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Is the surgical treatment of patients with coronary heart disease using the T-graft technique an adequate solution that provides a sufficient myocardial flow reserve? A magnetic resonance examination (MRI) is required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
patients scheduled for bypass grafting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgical procedure
Arm Type
Other
Arm Description
T-graft bypass or conventional bypass
Intervention Type
Procedure
Intervention Name(s)
T-Graft
Intervention Description
T-Graft
Primary Outcome Measure Information:
Title
Coronary flow reserve
Time Frame
within 4-6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary heart disease
Age > 18 ys
Ejection fraction > 45%
Exclusion Criteria:
myocardial infarction
Re-Intervention
Facility Information:
Facility Name
Johann Wolfgang Goethe Universitätsklinikum
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
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Coronary Flow Rate Measurement in T-Grafts
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