1) identifying new predictors of ST, in particular of late and very late ST and drug eluting stent thrombosis2) to observe clinical outcome after an episode of a ST
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical, biochemical, angiographic, procedural, haematological,
histopathological, genetic, visual (by means of OCT) and follow-up
characteristics
Secondary outcome
Bleedings according to the TIMI criteria
Background summary
Stent thrombosis (ST) is a serieus complication of percutaneous coronary
interventions (PCI) with stent implantation. Stent thrombosis complicates
approximately 2-4 % of alle PCI's en is associated with high morbidity and
mortality rates. Further research after stent thrombosis is urgently needed, to
identify those patients at risk en to gain more insigh in the pathophysiology
of ST. However, previous studies after ST have been hampered by a small sample
size en small numbers of patients with 'drug eluting' stent thrombosis and late
and very late ST.
Study objective
1) identifying new predictors of ST, in particular of late and very late ST and
drug eluting stent thrombosis
2) to observe clinical outcome after an episode of a ST
Study design
multicenter, matched case control study
Study burden and risks
During PCI (according to institutional standards), 50 mL of blood will be
collected of all patients. Performance of OCT (when indicated) is encouraged.
Consequently, thrombus will be aspirated from the coronary artery.
During hospitalisation, patients will be asked to fulfill a questionnaire
regarding potential triggering mechanisms of ST. Patients will be asked to
visit the hospital after the acute phase to donate blood in order to perform
platelet function testing. Finally, patients will be contacted for followup
details.
Patients which will be included retrospectively, will be asked to visit the
hospital once for blood donating. When they do not want to visit the hospital
they will be asked to donate saliva via saliva containers for DNA donating.
These saliva containers will be sent to their homes and they can send it back
to the hospital for free.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
all patients suffering a stent thrombosis
Exclusion criteria
Abcense of an informed consent.;If a case or matched control patient dies before written Informed Consent could be obtained the clinical data will be used for the study, but only if the researcher doesn*t have any suggestion that the patient would have declined his consent if he still would have been alive. The researcher will write a note in the CRF stating this assumption. The family will not be contacted and no blood samples will be stored.
Design
Recruitment
Medical products/devices used
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 | NL29798.100.09 |