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A Randomised Trial Comparing Same-Day Discharge with Overnight Hospital Stay after Elective Percutaneous Coronary Intervention: the Elective Percutaneous Coronary Intervention in Outpatient Study.

A Randomised Trial Comparing Same-Day Discharge with Overnight Hospital Stay after Elective Percutaneous Coronary Intervention: the Elective Percutaneous Coronary Intervention in Outpatient Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24859
Enrollment
800
Registered
2005-08-30
Start date
2000-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina.

Interventions

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

Sponsors

Academic Medical Centre-University of Amsterdam Meibergdreef 15 1105 AZ Amsterdam Netherlands tel: 31 20 5669111
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactG.S. Heyde

Academic Medical Center (AMC), Department of Cardiology, P.O. Box 22660

g.s.heyde@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)