Coronary Artery DiseaseNCT00419055
Outpatient Percutaneous Coronary Intervention
An observational study of Coronary Artery Disease, run by University of Pennsylvania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Early discharge after percutaneous coronary intervenntion
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Aug 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients less than 75 years who have undergone PCI
Who may be able to join
- Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention
Who cannot join
- 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)
About this study
Official title: Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Early discharge after percutaneous coronary intervenntion
- Keywords
- percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early discharge after percutaneous coronary intervenntionProcedure or surgery
Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.
| Study group | Role | What they receive |
|---|---|---|
| 1 Control | Patients are discharged the day after PCI Receives: Procedure: Early discharge after percutaneous coronary intervenntion | |
| 2 Study group | Patients will be discharged 4-6 hrs after PCI Receives: Procedure: Early discharge after percutaneous coronary intervenntion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints are patient satisfaction and safety.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startAug 2004
- Study completionAug 2006
Why it stopped: Stopped early due to inability to recruit full 100 subjects over 2 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, The Medicines Company
- Responsible party
- Sponsor
- Investigators
- Howard C Herrmann, M.D., Principal investigator, University of PennsylvaniaRuchira Glaser, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419055
- Sponsor's protocol ID
- 801441
- Status last verified
- Mar 2012
- First submitted
- 4 Jan 2007
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population
- ClinicalTrials.gov ID
- NCT00419055
- Acronym / sponsor ID
- 801441
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stopped early due to inability to recruit full 100 subjects over 2 years
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, The Medicines Company
- Study start
- Aug 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Jan 2007 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Control | – | Procedure: Early discharge after percutaneous coronary intervenntionPatients are discharged the day after PCI |
| 2 Study group | – | Procedure: Early discharge after percutaneous coronary intervenntionPatients will be discharged 4-6 hrs after PCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients less than 75 years who have undergone PCI
Key inclusion criteria (1 listed)
- Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early discharge after percutaneous coronary intervenntionEligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal. | Procedure or surgery | 1 Control, 2 Study group |
Primary outcome
The primary endpoints are patient satisfaction and safety.
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Stopped early due to inability to recruit full 100 subjects over 2 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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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.
Howard C Herrmann, M.D. principal investigator
University of Pennsylvania
Ruchira Glaser, M.D. principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Pennsylvania.
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 1 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: stopped early, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Stopped early due to inability to recruit full 100 subjects over 2 years). Results are not available in the source record.
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?
The primary endpoints are patient satisfaction and safety. (time frame: 30 days). 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 2 Apr 2012.