Status:
TERMINATED
Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge
Lead Sponsor:
Trinity Health Michigan
Collaborating Sponsors:
Michigan Heart, PC
Blue Cross Blue Shield of Michigan Foundation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the total costs of care associated with uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through 30-day follow up ar...
Detailed Description
This is a prospective randomized clinical trial of same day discharge versus overnight stay for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated post-PCI recovery. ...
Eligibility Criteria
Inclusion
- Consecutive patients who undergo elective or low-risk, (i.e., in the setting of unstable angina but not non-ST segment elevation myocardial infarction) urgent PCI.
- No sociodemographic factors that would preclude SDD (prohibitive factors include no family member/friend available to remain with patient until nurse phone call the following day, no working phone, no reliable transportation, home \> 60 minutes from medical infrastructure, unable to obtain/pay for medications).
- PCI procedures performed between 08/04/14 and 08/03/16.
- Short term risk of in-hospital death, transfusion or contrast-induced nephropathy during the index hospitalization at or below 1% using Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) PCI registry risk prediction models.
- No in-lab complications (prolonged angina, acute closure, no reflow, significant or untreated dissection, vessel perforation, side branch occlusion, rescue glycoprotein IIb/IIIa inhibitor use, ventricular tachycardia or fibrillation requiring cardioversion/defibrillation, tamponade, pulmonary edema, stroke or transient ischemic attack, shock).
- Contrast Volume/Calculated Creatinine Clearance ratio \< 3
- No recurrent chest pain, shortness of breath, hemodynamic instability, bleeding or vascular complications during 6 hours in recovery area post-PCI
Exclusion
- Use of rotational atherectomy
- Use of a glycoprotein IIb/IIIa inhibitor infusion post-PCI
Key Trial Info
Start Date :
August 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02207270
Start Date
August 11 2014
End Date
September 1 2015
Last Update
March 22 2018
Active Locations (2)
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1
Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
Ypsilanti, Michigan, United States, 48197
2
Saint Jospeh Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory
Ypsilanti, Michigan, United States, 48197