1) To identify new predictors of ST, in particular of late and very late ST, and of drug eltuing stent thrombosis. 2) To observe clinical outcomes after an episode of 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/IVUS) and follow-up
characteristics.
Secondary outcome
Not applicable.
Background summary
Stent thrombosis (ST) is a serious complication of percutaneous coronary
intervention (PCI) with stent implantation. Stent thrombosis complicates
approximately 0.5-4% of all PCI's and is associated with high morbidity
(recurrence myocardial infarction, poor left ventricular function and
recurrence ST) and high mortality rates.
Further research after ST is urgently needed, to identify those patients at
high risk and to gain more insight in the pathophysiology of ST. However,
previous studies after ST have been hampered by a small sample size and small
numbers of patients with late and very late ST' and 'drug eluting' stent
thrombosis.
Study objective
1) To identify new predictors of ST, in particular of late and very late ST,
and of drug eltuing stent thrombosis.
2) To observe clinical outcomes after an episode of ST.
Study design
Multicenter, matched case-control study
Study burden and risks
Patients presenting with ST will undergo PCI according best clinical practice
of institutional standards. 50 mL blood will be collected from all patients.
When thrombosuction is performed, the thrombus will be collected and analysed.
Performance of OCT/IVUS will be encouraged. During hospitalisation, patients
will be asked to fulfill a questionnaire regarding potential triggering
mechanisms of ST. Patients will be asked to visit the outpatient clinic 30-60
days after the acute phase for blood sampling and urine collection in order to
perform blood platelet function testing. Finally, patients will be contacted 30
days, 1, 2, and 3 years after ST for follow-up information.
The risks for patients when participating this study will be little.
Performance of OCT/IVUS can result in 'chest discomfort', however, with the
improvement of the equipment it can be expected that this risk will decline.
Advantages of OCT/IVUS performance for the patient can possibly be a more
accurate implantation of the stent and better PCI results.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
Cases: all patients suffering a stent thrombosis
Controls: patients without ST who underwent PCI with stent implantation on the same date (±5 days) of index PCI of matched case, in the same interventional centre and with the same indication will be enrolled.
Exclusion criteria
Absence 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 | NL36259.100.11 |