NCT01170988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

4 years

First QC Date

July 27, 2010

Last Update Submit

August 5, 2014

Conditions

Coronary Heart Disease

Keywords

patients scheduled for bypass grafting

Outcome Measures

Primary Outcomes (1)

  • Coronary flow reserve

    within 4-6 weeks

Study Arms (1)

surgical procedure

OTHER

T-graft bypass or conventional bypass

Procedure: T-Graft

Interventions

T-GraftPROCEDURE

T-Graft

surgical procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • myocardial infarction
  • Re-Intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe Universitätsklinikum

Frankfurt am Main, 60590, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head cardiovascular research

Study Record Dates

First Submitted

July 27, 2010

First Posted

July 28, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

DE(1)