1) To identify new predictors of ST, especially 'late' and 'very late ST', 'drug eluting ST' and 'bio-absorbable scaffold thrombosis'.2) To observe clinical outcome 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, angiographic, procedural, hematological, histopathological, genetic,
visual (by means of OCT) en follow-up characteristics.
Secondary outcome
Not applicable.
Background summary
Stent Thrombosis (ST) is a serious complication of percutaneous coronary
intervention (PCI) with stent implantation. ST has a major clinical impact with
a high risk of myocardial infarction (MI) in 80% of the cases and death in 12%
to 40% of the cases. Further research is urgently needed to identify those
patients at high risk and to gain insight in the pathophysiology of ST.
Previous studies have been hampered by small sample size, in particular
regarding the number of patients with 'late' (>30 days after stent
implantation) and 'very late ST'(>12 months after stent implantation), patients
with drug-eluting stent thrombosis and bio-absorbable scaffhold thrombosis.
Study objective
1) To identify new predictors of ST, especially 'late' and 'very late ST',
'drug eluting ST' and 'bio-absorbable scaffold thrombosis'.
2) To observe clinical outcome after an episode of ST
Study design
Multicenter prospective registry study
Study burden and risks
Patients presenting with ST will undergo PCI according the best clinical
practice of institutional standards. 4.5 - 6 ML of blood will be collected from
all patients, when this is not possible during PCI, blood will be collected
after the procedure via venipuncture. When thrombus aspiration is performed,
the thrombus will be collected for future analysis. Performance of OCT will be
encouraged. During hospitalisation, patients will be asked to fill in a
questionnaire regarding potential triggering mechanisms of ST. Finally,
patients will be contacted (if necessary) 1, 2 and 3 years after ST for
follow-up information. The risks are considered relatively low for patients,
when participating in this study. Performance of OCT can result in chest
discomfort, however it is expected that this risk will decline with the new
systems with high speed pullbacks that permit coronary imaging in a few
seconds. Possible advantages of OCT performance for the patient are 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 stent thrombosis who underwent PCI with stent implantation on the same date (± 14 days) of index PCI of matched cases, in the same interventional centre and with the same indication as the matched cases will be enrolled.
Exclusion criteria
The absence of an informed consent (IC).
If a case patient dies before written IC could be obtained, the clinical data will be used for the study only if the researcher does not have any suggestion that the patient would have declined his consent if he would still be alive. The researcher will make 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 | NL57084.100.16 |