To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery InterventionNCT01276132
Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program
An observational study of To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2010to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age 18 and up
- undergoes coronary angiography in the Cardiac Catheterization Laboratory
Who cannot join
- if the subject declines participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
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.
- Keywords
- percutaneous coronary artery intervention, coronary disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects who are designated to receive same-day PCI | Not described | |
| Subjects who had been admitted to the hospital after their PCI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinical outcomes, safety, and satisfaction of patients who have participated in a same-day outpatient percutaneous coronary artery intervention program
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study start1 Jun 2010
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery InterventionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atman Shah, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276132
- Sponsor's protocol ID
- 10-291-A
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2011
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program
- ClinicalTrials.gov ID
- NCT01276132
- Acronym / sponsor ID
- 10-291-A
- Keywords
- percutaneous coronary artery intervention, coronary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects who are designated to receive same-day PCI | – | – |
| Subjects who had been admitted to the hospital after their PCI | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- age 18 and up
- undergoes coronary angiography in the Cardiac Catheterization Laboratory
Key exclusion criteria (1 listed)
- if the subject declines participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atman Shah, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.