Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention

NCT01230606 | Completed DMC

• 1 other identifier: GCO 07-1324
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cardiovascular Disease

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Patient satisfaction with timing of discharge

  30 days after enrollment

• Patient Satisfaction Outcome Assessment

  30 days After Enrollment

Study Arms (2)

overnight

Subjects that stay overnight at the hospital.

Other: discharge vs. overnight stay

Next Day Discharge

Subjects that are discharged on the same day of the procedure.

Other: discharge vs. overnight stay

Interventions

discharge vs. overnight stay OTHER

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.

Next Day Discharge; overnight

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \<75 years of age at the time of procedure.
• \. Patient has a type A or B lesion(s)
• \. Femoral access site is amenable to closure with a vascular closure device.
• \. 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Abbott Medical Devices: collaborator

Study Sites (2)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

Related Publications (1)

• 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.

  PMID: 23481528 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael C Kim, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: October 29, 2010
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

US (2)