Outpatient Percutaneous Coronary Intervention

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Early discharge after percutaneous coronary intervenntion

• Registration Number: NCT00419055
• Lead Sponsor: University of Pennsylvania

Brief Summary

To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

Detailed Description

A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Study Timeline

• Study Start: 2004-08
• Study Completion: 2006-08
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-29
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention

Exclusion Criteria

• Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction <30%, those with history of IV Dye allergy, creatinine level>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin<11.0 g/dl, platelets <100,000 tho/ul)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 Control	Early discharge after percutaneous coronary intervenntion	Patients are discharged the day after PCI
2 Study group	Early discharge after percutaneous coronary intervenntion	Patients will be discharged 4-6 hrs after PCI

Primary Outcome Measures

Name	Time	Method
The primary endpoints are patient satisfaction and safety.	30 days