ABCD-PCI
Ambulatory Closure Device Percutaneous Intervention: a Multi-Center Randomized Trial Evaluating Patient Satisfaction, Safety, and Cost Effectiveness of Ambulatory PCI in the Current Era
Sponsor study identifier
observational
303
1 country
2
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 31, 2010
Actual (reported)June 2010
Actual (reported)June 2010
Actual (reported)October 29, 2010
Actual (reported)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.
30 days after enrollment
Patient satisfaction with timing of discharge
30 days after enrollment
Patient Satisfaction Outcome Assessment
30 days After Enrollment
Subjects that stay overnight at the hospital.
Subjects that are discharged on the same day of the procedure.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Mount Sinai School of Medicine
New York, New York, 10029, United States
Baylor University Medical Center
Dallas, Texas, 75226, United States
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.
Michael C Kim, MD
Icahn School of Medicine at Mount Sinai
303 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2010
First Posted
October 29, 2010
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of Processed Tomato Products on CVD Risks
Contact the study team to confirm eligibility.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
July 28, 2011
Record last verified: 2011-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: