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Coronary Flow Rate Measurement in T-Grafts

This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
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: June 4, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

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
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170988

Contacts
Contact: Arndt H Kiessling, MD +49696301 ext 87015 arndt.kiessling@kgu.de

Locations
Germany
Johann Wolfgang Goethe Universitätsklinikum Recruiting
Frankfurt am Main, Germany, 60590
Contact: Arndt H Kiessling, MD     +49 69 6301 ext 87015     arndt.kiessling@kgu.de    
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: June 4, 2012
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013