Outpatient Percutaneous Coronary Intervention - Full Text View

Sponsors and Collaborators:	University of Pennsylvania St. Jude Medical The Medicines Company
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00419055

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Procedure: Early discharge after percutaneous coronary intervenntion	Phase II Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Bivalirudin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

The primary endpoints are patient satisfaction and safety. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	August 2004
Estimated Study Completion Date:	August 2006

Groups/Cohorts	Assigned Interventions
1 Control Patients are discharged the day after PCI	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.
2 Study group Patients will be discharged 4-6 hrs after PCI	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients less than 75 years who have undergone PCI

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419055

Sponsors and Collaborators

University of Pennsylvania

St. Jude Medical

The Medicines Company

Investigators

Principal Investigator:	Howard C Herrmann, M.D.	University of Pennsylvania
Principal Investigator:	Ruchira Glaser, M.D.	University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( Howard Herrmann, M.D. )
Study ID Numbers:	801441
Study First Received:	January 4, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00419055
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

percutaneous coronary intervention

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Bivalirudin
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009