The purpose of this audit is to demonstrate the long-term patency of Corlink device compared to the standard "coronary artery bypass grafting (CABG). We also offer this to patients in the study population an extra quality
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patency of the bypass grafts
Secondary outcome
n.a.
Background summary
From 2001 to 2004 the research department of cardiothoracic surgery
participated in the Multi-center trial Corlink. The study took place in our
center and in the Amphia Hospital Breda. In summary this was an experimental
trial to the applicability of adhesion-free connections in the coronary artery
surgery. One of the most important primary endpoints of this study was the
so-called short-term patency of coronary bypass grafts (patency = good blood
flow in the diversion). The study found that using a coronary angiogram. For
more details, I refer you to the Protocol to METC METC No # M00/1616 & M03/1359
#. At the time the study was successfully completed.
However, as already mentioned above, patients participated in an experimental
trial. Because we always strive for quality care, we believe that the
participants in this study are entitled to a long-term control.
Until recently it was not really possible without an invasive coronary
angiogram to do an audit of coronary bypass surgery. However, we recently have
this opportunity. This is today possible using the 256 multi-slice computed
tomography. For that reason we would then have patients who participated in the
study Corlink now want a quality offer.
Study objective
The purpose of this audit is to demonstrate the long-term patency of Corlink
device compared to the standard "coronary artery bypass grafting (CABG). We
also offer this to patients in the study population an extra quality
Study design
We will we distill from our database, which patients in the study population
are still alive. These patients we through a letter or telephone call for
additional review. The audit will include an outpatient clinic where we visit a
short history and complete physical examination performed. In addition,
patients with written informed consent a CT scan of the heart undergo.
Study burden and risks
Minimal impact and risk.
Default risk due to contrast administration in CT scan.
Standard radiation exposure due to CT
Michelangelolaan 2
5623 EJ Eindhoven
NL
Michelangelolaan 2
5623 EJ Eindhoven
NL
Listed location countries
Age
Inclusion criteria
Participation in the Corlink Study
Exclusion criteria
Atrialfibrilation
Severe renale dysfunction
coronary angiogram in past year
cardiac ct-scan in past year
re-cabg
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL32826.060.10 |