No registrations found.
ID
Source
Brief title
Health condition
Stable angina.
Sponsors and support
Meibergdreef 15
1105 AZ Amsterdam
Netherlands
tel: 31 20 5669111
P.O. box 320
1110 AH Diemen
Netherlands
www.cvz.nl
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the composite of major adverse cardiac events and severe complications of the arterial puncture with the need of blood transfusion or repeat compression, from randomization until 24 hours after PCI.
Secondary outcome
Secondary endpoints are the indication for extended observation, the occurrence of major adverse cardiac events and puncture site complications from randomization until 30 days after PCI, quality of life scores before and after PCI, actual costs related to PCI, aftercare and 30 days follow-up.
Background summary
N/A
Study objective
The Elective PCI in Outpatient Study (EPOS) is designed to evaluate the safety and feasibility of discharge the same day as PCI, by testing the hypothesis that patients requiring extended observation can be selected effectively and that same-day discharge does not increase the complication rate as compared to overnight hospital stay.
Study design
N/A
Intervention
After percutaneous coronary intervention, patients are observed for 4 hours.
Patients randomized to same-day discharge are ambulated after this period and discharged. Patients randomized to overnight stay are discharged the following day. Indications for extended hospital stay are based on pre-defined clinical and angiographic criteria.
Department of Cardiology,
P.O. Box 22660
G.S. Heyde
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
g.s.heyde@amc.uva.nl
Department of Cardiology,
P.O. Box 22660
G.S. Heyde
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
g.s.heyde@amc.uva.nl
Inclusion criteria
All patients scheduled to undergo elective percutaneous coronary intervention in the Academic Medical Centre in Amsterdam who remain at home prior to the procedure.
Exclusion criteria
1. Scheduled use of guiding catheters larger than 6 French (F) in diameter;
2. Elective use of glycoprotein 2b/3a receptor blockers;
3. Long term systemic anti-coagulation;
4. Residence of more than 60 minutes drive from an intervention center;
5. No adult care person available at home for first 24 hours after PCI;
6. Diagnostic coronary artery catheterization with possible ad hoc PCI.
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 |
|---|---|
| NTR-new | NL134 |
| NTR-old | NTR168 |
| Other | : N/A |
| ISRCTN | ISRCTN75891755 |