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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
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring patients scheduled for bypass grafting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
July 27, 2010
Last Updated
August 5, 2014
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Bethanien Krankenhaus gGmbH
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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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