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Outpatient Percutaneous Coronary Intervention

This study has been terminated.
(Stopped early due to inability to recruit full 100 subjects over 2 years)
Sponsor:
Collaborators:
St. Jude Medical
The Medicines Company
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00419055
First received: January 4, 2007
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  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 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 100
Study Start Date: August 2004
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

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00419055     History of Changes
Other Study ID Numbers: 801441
Study First Received: January 4, 2007
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013