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Outpatient Percutaneous Coronary Intervention

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University of Pennsylvania

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Procedure: Early discharge after percutaneous coronary intervenntion

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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