An interventional study of Percutaneous coronary intervention (PCI) in Coronary Arteriosclerosis and Angina Pectoris, sponsored by Johns Hopkins University. Completed at 60 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents. Most U.S. states and all national heart organizations require that angioplasty be done only at hospitals that can also perform open heart surgery. The reason for this is that there is a risk that angioplasty can cause injury to the heart artery that might require open heart surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart surgery will be needed is very small. Nevertheless, without more research, many state Departments of Health and all national heart organizations do not want to change the requirement for having on-site open heart surgery wherever angioplasty is performed. Some States already allow this; and European heart organizations already allow it, as well.
This study is designed to determine whether the safety and benefits of angioplasty are the same at hospitals that perform angioplasty either with or without open heart surgery backup.
Patient who enter the study have a heart catheterization at a hospital without a heart surgery program. If they need angioplasty, then they are randomized to either stay at the hospital without heart surgery for their angioplasty or to be transferred for the procedure to a hospital with heart surgery. For every four patients, three stay at the hospital without heart surgery and one is transferred.
The study is designed to show that there is no detectable difference between the safety and benefits of the procedure at the two types of hospital (with and without heart surgery). The cost of the procedure at the two hospital types is also compared.
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's enrollment of 18,876 is above the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Johns Hopkins University is the lead sponsor of 1,782 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pre-catheterization:
Post-catheterization:
Exclusion Criteria:
Pre-catheterization:
Post-catheterization:
High procedural risk criteria are:
PCI performed at a hospital with co-located (on-site) cardiac surgery
Other: Percutaneous coronary intervention (PCI)
PCI performed at a hospitals without co-located (on-site) cardiac surgery
Other: Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
Mortality
Time frame: 6 weeks
MACE = death + MI + TVR
Time frame: 9 Months
emergency CABG
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
myocardial infarction
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
target vessel revascularization (TVR)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
any subsequent revascularization (ASR)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
heart failure and class
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
angina and class
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
stroke
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
composite adverse endpoint (MACE)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
MACE = death + MI + TVR
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
MACE = death + MI + ASR
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
completeness of revascularization
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
percent of patients with complete or partial revascularization
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
bleeding (non-CABG transfusion, vascular repair)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
length of stay
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
total direct medical cost
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)
Time frame: hosp DC, 6 wks, 3, 6 and 9 months
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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