Cardiovascular DiseaseABCD-PCINCT01230606
Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention
An observational study of Cardiovascular Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24 hours after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- discharge vs. overnight stay
- How many people
- 303 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jun 2010
- 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: The target population for this study will include patients undergoing an elective PCI. Overall, 600 patient will be recurited from two sites in the United Sates. As this is a feasiblity study, enrollment will be restricted to low-risk patients. For this reason, the study will be limited to patients under 75 years of age. All patients must meet all of the inclusion criteria and have none of the exclusion criteria to be enrolled into the study.
Who may be able to join
- . <75 years of age at the time of procedure.
- 2. Patient has a type A or B lesion(s)
- 3. Femoral access site is amenable to closure with a vascular closure device.
- 4. Over 2 hours since the completion of the PCI procedure (at least 2 hours must elapse from completion of the PCI before subjects become eligible).
Who cannot join
- Patient has a life expectancy less than 12 months.
- Patient has recent evidence of an acute coronary syndrome (MI)
- Femoral access is difficult or site is not amenable to closure device
- Anticoagulants other than unfractionated heparin or bivalirudin were used during the procedure (i.e. enoxaparin).
- Patient has sub optimal angiographic outcome or clinical complication(s) during PCI
- The PCI occurred in something other than a native coronary artery
Show all 18Show fewer
- Angiographic evidence of thrombus
- Patient has more than 3 stents implanted during this PCI
- Patient has an INR >2, Platelet count <100,000 or Hematocrit <25
- Occlusion of major side branch during PCI of >1.5mm
- Patient has ejection fraction ≤30%
- Known allergy to PCI procedural medications
- Patient reports living further than 30 minutes from a hospital by ambulance.
- Patient provides informed consent and agrees to the follow-up schedule.
- Evidence of vascular complication(s) (e.g. dissection, hematoma, bleeding) peri-procedure
- Patient is pregnant
- Evidence of infection (e.g. fever, pus, swelling) peri-procedure
- Patients with chronic renal insufficiency (e.g. serum creatinine ≥1.5 mg/dL)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor University Medical Center
Dallas, Texas, 75226
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Ambulatory Closure Device Percutaneous Intervention: a Multi-Center Randomized Trial Evaluating Patient Satisfaction, Safety, and Cost Effectiveness of Ambulatory PCI in the Current Era
This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24 hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and will have a study population of 600 patients over 6 investigational sites all within the United States. Patients <65 years old will be chosen in order to stay within the low risk group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit. The primary endpoint will be a composite of major adverse cardiac and cerebral events, and the incidence of major bleeding or vascular complications. Data acquired from the study, such as blinded financial information and patient satisfaction surveys, will be used in order to evaluate cost analysis and safety of the procedure.
Read the detailed description
Closure devices are a relatively new method for sealing the femoral arterial puncture following procedures including percutaneous intervention (PCI). Because the risk of severe complications (e.g., bleeding, myocardial infarction, stroke, and mortality) associated with PCI when closure devices are very low, many patients undergoing PCI may be considered eligible for a same day hospital discharge. As the practice of ambulatory PCI is becoming more common, it is important to evaluate the readiness of patients under-going PCI for same-day discharge and anxiety and coping abilities of patients post-discharge. Our hypothesis is that same day discharge of patients who have undergone a PCI procedure with closure using a vascular closure device is safe, patients will be comfortable with a same day discharge and this process will be more cost efficient than the current standard of staying in the hospital overnight. The current pilot study is a multi-center, randomized parallel arm, controlled trial of low-risk patients undergoing an elective PCI procedure. Overall, 600 patients will be enrolled. After providing informed consent, participants will be randomized to leave the hospital on the same day as the PCI procedure or stay overnight in a 1:1 ratio. Data collection includes a self-administered questionnaire at hospital discharge, telephone interviews at 7-days and 30-days post-hospital discharge, and chart abstraction. The primary outcome for this study is differences across randomization arm in patient satisfaction scores on the validated 10-item Post-discharge coping difficulty scale assessed 7 days post-discharge. Secondary outcomes will include differences across randomization group for symptoms of anxiety, readiness for hospital discharge, patient satisfaction with the timing of their discharge, post-procedure pain and soreness, and cost-savings. While a data safety monitoring board will track all adverse events (i.e., myocardial infarction, hematoma, hospitalizations, and mortality), we anticipate too few events to occur to make meaningful inferences beyond that PCI is safe regardless of the timing of hospital discharge. The data from this pilot study will determine the comfort patients experience after undergoing PCI with an ambulatory (i.e, same-day) hospital discharge. Furthermore, this pilot study will provide the foundation for a large scale non-inferiority study of same-day discharge on outcomes including myocardial infarction, bleeding, and mortality. Such data will indicate the overall feasibility of early ambulatory PCI and has the potential to radically alter health care delivery following PCI.
- Conditions
- Cardiovascular Disease
- Being tested
- discharge vs. overnight stay
- Keywords
- Percutaneous Intervention, Percutaneous Coronary Intervention, Catheterization, Coronary Catheterization, Same day Discharge, Next Day Discharge, Patient Satisfaction, Multi-Center, Randomized, Low-risk PCI, BlindedClosure device, Vascular closure device
- Medical subject headings
- Cardiovascular Diseases, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discharge vs. overnight stayOther
At six hours post-PCI,patients will be randomized to be discharged immediately or to stay overnight in the hospital for observation and discharged the following day. Randomization will occur in a 1:1 ratio. Additionally, randomization will be performed stratified by study site.
| Study group | Role | What they receive |
|---|---|---|
| overnight | Subjects that stay overnight at the hospital. Receives: Other: discharge vs. overnight stay | |
| Next Day Discharge | Subjects that are discharged on the same day of the procedure. Receives: Other: discharge vs. overnight stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-hospitalization patient satisfaction
The primary endpoint is the difference in post-hospitalization patient satisfaction during the initial seven days following PCI. Post-hospitalization patient satisfaction will be assessed using the 10-item Post-Discharge Coping Difficulty scale.
Measured: 30 days after enrollment
Secondary outcomes (2)
Patient satisfaction with timing of discharge
Secondary outcomes will include post-hospital anxiety, readiness for hospital discharge, patient satisfaction with the timing of their discharge, post-procedure pain and soreness, resource utilization and cost-savings.
Measured: 30 days after enrollment
Patient Satisfaction Outcome Assessment
These outcomes will be assessed using standardized questionnaires and validated techniques. The composite of major adverse cardiac events (MACE) and cerebral events and the incidence of major bleeding or vascular complications will be monitored for all patients through the 30 day follow-up period.
Measured: 30 days After Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Investigators
- Michael C Kim, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230606
- Sponsor's protocol ID
- GCO 07-1324
- Acronym
- ABCD-PCI
- Status last verified
- Jul 2011
- First submitted
- 31 Mar 2010
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim M, Muntner P, Sharma S, Choi JW, Stoler RC, Woodward M, Mann DM, Farkouh ME. Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous coronary intervention: results from a pilot randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):186-92. doi: 10.1161/CIRCOUTCOMES.111.000069. Epub 2013 Mar 12.
PubMed 23481528
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Closure Device Percutaneous Intervention: a Multi-Center Randomized Trial Evaluating Patient Satisfaction, Safety, and Cost Effectiveness of Ambulatory PCI in the Current Era
- ClinicalTrials.gov ID
- NCT01230606
- Acronym / sponsor ID
- ABCD-PCI / GCO 07-1324
- Conditions
- Cardiovascular Disease
- Keywords
- Percutaneous Intervention, Percutaneous Coronary Intervention, Catheterization, Coronary Catheterization, Same day Discharge, Next Day Discharge, Patient Satisfaction, Multi-Center
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Oct 2010 (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.
This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24 hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and will have a study population of 600 patients over 6 investigational sites all within the United States. Patients <65 years old will be chosen in order to stay within the low risk group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit. The primary endpoint will be a composite of major adverse cardiac and cerebral events, and the incidence of major bleeding or vascular complications. Data acquired from the study, such as blinded financial information and patient satisfaction surveys, will be used in order to evaluate cost analysis and safety of the procedure.
Detailed description
Closure devices are a relatively new method for sealing the femoral arterial puncture following procedures including percutaneous intervention (PCI). Because the risk of severe complications (e.g., bleeding, myocardial infarction, stroke, and mortality) associated with PCI when closure devices are very low, many patients undergoing PCI may be considered eligible for a same day hospital discharge. As the practice of ambulatory PCI is becoming more common, it is important to evaluate the readiness of patients under-going PCI for same-day discharge and anxiety and coping abilities of patients post-discharge. Our hypothesis is that same day discharge of patients who have undergone a PCI procedure with closure using a vascular closure device is safe, patients will be comfortable with a same day discharge and this process will be more cost efficient than the current standard of staying in the hospital overnight. The current pilot study is a multi-center, randomized parallel arm, controlled trial of low-risk patients undergoing an elective PCI procedure. Overall, 600 patients will be enrolled. After providing informed consent, participants will be randomized to leave the hospital on the same day as the PCI procedure or stay overnight in a 1:1 ratio. Data collection includes a self-administered questionnaire at hospital discharge, telephone interviews at 7-days and 30-days post-hospital discharge, and chart abstraction. The primary outcome for this study is differences across randomization arm in patient satisfaction scores on the validated 10-item Post-discharge coping difficulty scale assessed 7 days post-discharge. Secondary outcomes will include differences across randomization group for symptoms of anxiety, readiness for hospital discharge, patient satisfaction with the timing of their discharge, post-procedure pain and soreness, and cost-savings. While a data safety monitoring board will track all adverse events (i.e., myocardial infarction, hematoma, hospitalizations, and mortality), we anticipate too few events to occur to make meaningful inferences beyond that PCI is safe regardless of the timing of hospital discharge. The data from this pilot study will determine the comfort patients experience after undergoing PCI with an ambulatory (i.e, same-day) hospital discharge. Furthermore, this pilot study will provide the foundation for a large scale non-inferiority study of same-day discharge on outcomes including myocardial infarction, bleeding, and mortality. Such data will indicate the overall feasibility of early ambulatory PCI and has the potential to radically alter health care delivery following PCI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| overnight | – | Other: discharge vs. overnight staySubjects that stay overnight at the hospital. |
| Next Day Discharge | – | Other: discharge vs. overnight staySubjects that are discharged on the same day of the procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study will include patients undergoing an elective PCI. Overall, 600 patient will be recurited from two sites in the United Sates. As this is a feasiblity study, enrollment will be restricted to low-risk patients. For this reason, the study will be limited to patients under 75 years of age. All patients must meet all of the inclusion criteria and have none of the exclusion criteria to be enrolled into the study.
Key inclusion criteria (4 listed)
- . <75 years of age at the time of procedure.
- 2. Patient has a type A or B lesion(s)
- 3. Femoral access site is amenable to closure with a vascular closure device.
- 4. Over 2 hours since the completion of the PCI procedure (at least 2 hours must elapse from completion of the PCI before subjects become eligible).
Key exclusion criteria (18 listed)
- Patient has a life expectancy less than 12 months.
- Patient has recent evidence of an acute coronary syndrome (MI)
- Femoral access is difficult or site is not amenable to closure device
- Anticoagulants other than unfractionated heparin or bivalirudin were used during the procedure (i.e. enoxaparin).
- Patient has sub optimal angiographic outcome or clinical complication(s) during PCI
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 |
|---|---|---|
| discharge vs. overnight stayAt six hours post-PCI,patients will be randomized to be discharged immediately or to stay overnight in the hospital for observation and discharged the following day. Randomization will occur in a 1:1 ratio. Additionally, randomization will be performed stratified by study site. | Other | Next Day Discharge, overnight |
Primary outcome
Post-hospitalization patient satisfaction
Time frame: 30 days after enrollment
The primary endpoint is the difference in post-hospitalization patient satisfaction during the initial seven days following PCI. Post-hospitalization patient satisfaction will be assessed using the 10-item Post-Discharge Coping Difficulty scale.
2 secondary outcomes
Patient satisfaction with timing of discharge
Time frame: 30 days after enrollment
Patient Satisfaction Outcome Assessment
Time frame: 30 days After Enrollment
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 28 Jul 2011.
- Derived from this study: PubMed 23481528Kim M, Muntner P, Sharma S, Choi JW, Stoler RC, Woodward M, Mann DM, Farkouh ME. Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous coronary intervention: results from a pilot randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):186-92. doi: 10.1161/CIRCOUTCOMES.111.000069. Epub 2013 Mar 12.
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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.
Michael C Kim, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 4 inclusion and 18 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 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Post-hospitalization patient satisfaction (time frame: 30 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230606, which also lists 1 linked publication.
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 28 Jul 2011; AzTrials last refreshed its copy on 26 Oct 2026.