Angiographic follow-up of DES in large patient groups late after primary PCI is currently unavailable. By extending the PASSION protocol, we have the opportunity to have the first angiographic analysis two to four years after primary PCI, both after…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A comparison of late angiographic parameters according to initial treatment
method, as well as (in a substudy) intravascular ultrasound meaurements.
Secondary outcome
Secondary endpoints include cinical endpoints as major adverse cardiovascular
events and anginal class.
Background summary
Long-term angiographic results after elective PCI with the use of BMS have
shown sustained efficacy several years after placement. This information
concerning stent-patency is currently lacking for stents placed during primary
PCI.
DES stents reduce the rate of both short-term and long-term in-stent restenosis
after elective PCI, compared to bare-metal stents. At present time, only
limited clinical data are available about the long-term implications of these
stents.
Study objective
Angiographic follow-up of DES in large patient groups late after primary PCI
is currently unavailable. By extending the PASSION protocol, we have the
opportunity to have the first angiographic analysis two to four years after
primary PCI, both after the placement of BMS as well as DES, in two
pre-specified groups with well matching clinical characteristics.
Study design
The original PASSION clinical study is a prospective, randomized, dual center,
single blinded study. Patients were treated randomly with Paclitaxel-eluting
stent(s) or a bare metal stent. These patients will be contacted to give
permission for a one-day admission to one of the two study centers to undergo
bicycle ergometry and coronary angiography, and intravascular ultrasound will
be performed in a subgroup of patients.
Study burden and risks
Admission on a one-day basis with diagnostic tests (bicycle ergometry, coronary
angiography).
Svere cardiovascular complications related to coronary angiography normally
occurs in apprximately 0.1%.
oosterpark 9
1091 AC Amsterdam
Nederland
oosterpark 9
1091 AC Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Treatment of acute myocardial infarction by primary PCI between 2003 and 2004, and included in the PASSION trial (published Sep 14 2006 in the New Engl J Med)
Exclusion criteria
renal insuffiency at risk for contrast nephropathy (creatinin > 130 mmol/L)
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 | NL15804.067.07 |