Coronary Flow Rate Measurement in T-Grafts

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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 3, 2013
Last verified: June 2013
  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
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

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 3, 2013
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 July 26, 2014