Coronary Flow Rate Measurement in T-Grafts
This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
Collaborator:
Bethanien Krankenhaus gGmbH
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01170988
First received: July 27, 2010
Last updated: June 4, 2012
Last verified: June 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 27, 2010 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Coronary flow reserve [ Time Frame: within 4-6 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01170988 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Coronary Flow Rate Measurement in T-Grafts | ||||
| Official Title ICMJE | Comparison of Coronary Flow Reserve in Two Different Bypass Techniques (T-graft Technique Versus Isolated Graft Technique) Using Magnetic Resonance Technology (MRT) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Coronary Heart Disease | ||||
| Intervention ICMJE | Procedure: T-Graft
T-Graft |
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| Study Arm (s) | surgical procedure
T-graft bypass or conventional bypass
Intervention: Procedure: T-Graft |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01170988 | ||||
| Other Study ID Numbers ICMJE | FLUSS001AHK | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals | ||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||
| Collaborators ICMJE | Bethanien Krankenhaus gGmbH | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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