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Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program

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ClinicalTrials.gov Identifier: NCT01276132
Recruitment Status : Recruiting
First Posted : January 13, 2011
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

Subjects in this study have recently had or are scheduled for a (percutaneous coronary intervention) PCI as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.

Recent studies have shown that stable patients who undergo PCI and are discharged home after 4 hours of observation do not suffer any more complications compared to patients who stay in the hospital overnight. In addition, studies suggest that patients express increased satisfaction at being discharged after 4 hours.

The University of Chicago is one of the first US medical centers to institute a formal program of same-day discharge after PCI. This study will seek, through a analysis of medical information and satisfaction questionnaires, to assess whether this particular same-day discharge program can improve patient satisfaction and preserve patient safety.

Condition or disease
To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program
Study Start Date : June 2010
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Subjects who are designated to receive same-day PCI
Subjects who had been admitted to the hospital after their PCI

Primary Outcome Measures :
  1. To evaluate clinical outcomes, safety, and satisfaction of patients who have participated in a same-day outpatient percutaneous coronary artery intervention program [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patient who presents to the Cardiac Catheterization Laboratory for coronary angiography will be given the opportunity to participate in this program. The determination on whether or not a patient is selected to undergo Same-Day PCI is based on the clinical decision of the practicing physician according to conventionally accepted inclusion and exclusion criteria. The decision on whether or not to participate in the questionnaire study will not affect any treatment decisions. The only exclusion criteria will be if the patient declines participation. The investigators would like to enroll 250 patients over a three year period.

Inclusion Criteria:

  • age 18 and up
  • undergoes coronary angiography in the Cardiac Catheterization Laboratory

Exclusion Criteria:

  • if the subject declines participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276132

Contact: Melanie Norstrom (773) 702-0347 mnorstrom@medicine.bsd.uchicago.edu

United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Melanie Norstrom, PhD    773-702-0347    mnorstrom@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Principal Investigator: Atman Shah, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01276132     History of Changes
Other Study ID Numbers: 10-291-A
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Keywords provided by University of Chicago:
percutaneous coronary artery intervention
coronary disease