Outpatient Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

Official title:

Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00419055
• Other study ID #: 801441
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: January 4, 2007
• Last updated: March 29, 2012
• Start date: August 2004
• Est. completion date: August 2006

Study information

• Verified date: March 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Early discharge after percutaneous coronary intervenntion
Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	St. Jude Medical, The Medicines Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoints are patient satisfaction and safety.		30 days	Yes