Coronary Flow Rate Measurement in T-Grafts

This study has been completed.
Sponsor:
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: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Procedure: T-Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Coronary Flow Reserve in Two Different Bypass Techniques (T-graft Technique Versus Isolated Graft Technique) Using Magnetic Resonance Technology (MRT)

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Coronary flow reserve [ Time Frame: within 4-6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
surgical procedure
T-graft bypass or conventional bypass
Procedure: T-Graft
T-Graft

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • coronary heart disease
  • Age > 18 ys
  • Ejection fraction > 45%

Exclusion Criteria:

  • myocardial infarction
  • Re-Intervention
  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: NCT01170988

Locations
Germany
Johann Wolfgang Goethe Universitätsklinikum
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Bethanien Krankenhaus gGmbH
  More Information

No publications provided

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01170988     History of Changes
Other Study ID Numbers: FLUSS001AHK
Study First Received: July 27, 2010
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
patients scheduled for bypass grafting

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014