Outpatient Percutaneous Coronary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1 Control

Patients are discharged the day after PCI

Early discharge after percutaneous coronary intervenntion

Intervention Type PROCEDURE

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

Early discharge after percutaneous coronary intervenntion

Intervention Type PROCEDURE

Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No