Angina Pectoris Clinical Trial
Official title:
Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
Verified date | September 2014 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18876 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Pre-catheterization: - Must be undergoing diagnostic cardiac catheterization for suspected CAD - Be at least 18 years of age - Must not be pregnant (negative pregnancy test) or must not be of childbearing potential must be able to give informed consent. Post-catheterization: - Coronary artery disease judged to be clinically and angiographically significant - Ability to perform PCI with equipment available at the local site - Procedure risk judged to be not high (see below) Exclusion Criteria: Pre-catheterization: - Inability to give informed consent - ST-segment elevation myocardial infarction - Pregnancy Post-catheterization: - High likelihood of requiring a device not available at the hospitals without SOS - No need for PCI - Need for coronary artery bypass surgery - High procedural risk (see below) High procedural risk criteria are: - PCI of unprotected left main coronary artery - PCI of left circulation lesion in the presence of critical (>70%) unprotected left main coronary artery lesion - Poor left ventricular function (EF< 20%) and need to perform PCI in a vessel supplying significant myocardium |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Sacred Heart Hospital | Allentown | Pennsylvania |
United States | Anne Arundel Medical Center | Annapolis | Maryland |
United States | Wellstar Cobb Hospital | Austell | Georgia |
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
United States | St. Agnes Hospital | Baltimore | Maryland |
United States | Bayonne Medical Center | Bayonne | New Jersey |
United States | Clara Maas Medical Center | Belleville | New Jersey |
United States | Southeast Georgia Health System | Brunswick | Georgia |
United States | Community Health and Wellness Center | Bryan | Ohio |
United States | Tanner Medical Center | Carrollton | Georgia |
United States | Chambersburg Hospital | Chambersburg | Pennsylvania |
United States | University Hospitals Case Medical Center / Geauga Medical Center | Chardon | Ohio |
United States | Southern Maryland Hospital Center | Clinton | Maryland |
United States | University Hospital East Ohio State University Medical Center | Columbus | Ohio |
United States | Hamilton Medical Center | Dalton | Georgia |
United States | Southview Medical Center | Dayton | Ohio |
United States | Fairview Park Hospital | Dublin | Georgia |
United States | JFK Medical Center | Edison | New Jersey |
United States | Trinitas Hospital | Elizabeth | New Jersey |
United States | Little Company of Mary Hospital | Evergreen Park | Illinois |
United States | Virtua-West Jersey Hospital Marlton | Evesham | New Jersey |
United States | Fort Hamilton Hospital | Fort Hamilton | Ohio |
United States | Frederick Memorial Hospital | Frederick | Maryland |
United States | Baltimore Washington Medical Center | Glen Burnie | Maryland |
United States | Spalding Regional Medical Center | Griffin | Georgia |
United States | Meritus Medical Center | Hagerstown | Maryland |
United States | Robert Wood Johnson Medical Center | Hamilton | New Jersey |
United States | Advocate South Suburban Hospital | Hazel Crest | Illinois |
United States | Crestwood Medical Center | Huntsville | Alabama |
United States | Kingwood Medical Center | Kingwood | Texas |
United States | Armstrong County Memorial Hospital | Kittanning | Pennsylvania |
United States | West Georgia Health | LaGrange | Georgia |
United States | Evangelical Community Hospital | Lewisburg | Pennsylvania |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | UPMC McKeesport | McKeesport | Pennsylvania |
United States | Meadville Medical Center | Meadville | Pennsylvania |
United States | Monongahela Valley Hospital | Monongahela | Pennsylvania |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Raritan Bay Medical Center | Perth Amboy | New Jersey |
United States | Legacy Meridian Park Hospital | Portland | Oregon |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Duke Health Raleigh Hospital | Raleigh | North Carolina |
United States | Riverview Medical Center | Red Bank | New Jersey |
United States | Southern Regional Medical Center | Riverdale | Georgia |
United States | Shady Grove Adventist Hospital | Rockville | Maryland |
United States | Rowan Regional Medical Center | Salisbury | North Carolina |
United States | Holy Cross Hospital | Silver Spring | Maryland |
United States | Somerset Medical Center | Somerville | New Jersey |
United States | Muhlenberg Regional Medical Center | South Plainfield | New Jersey |
United States | Overlook Medical Center | Summit | New Jersey |
United States | Holy Name Hospital | Teaneck | New Jersey |
United States | Mainland Medical Center | Texas City | Texas |
United States | Archbold Memorial Hospital | Thomasville | Georgia |
United States | Tift Regional Medical Center | Tifton | Georgia |
United States | Community Medical Center | Toms River | New Jersey |
United States | West Chester Hospital | West Chester | Pennsylvania |
United States | Mt. Carmel St. Ann's Hospital | Westerville | Ohio |
United States | Memorial Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Duke University, Maryland Medical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | 6 weeks | Yes | |
Primary | MACE = death + MI + TVR | 9 Months | Yes | |
Secondary | emergency CABG | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | myocardial infarction | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | target vessel revascularization (TVR) | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | any subsequent revascularization (ASR) | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | heart failure and class | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | angina and class | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | stroke | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | composite adverse endpoint (MACE) | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | MACE = death + MI + TVR | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | MACE = death + MI + ASR | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | angiographic (end-procedure) complications (embolization, dissection, no reflow, etc) | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow) | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | completeness of revascularization | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | percent of patients with complete or partial revascularization | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | bleeding (non-CABG transfusion, vascular repair) | hosp DC, 6 wks, 3, 6 and 9 months | Yes | |
Secondary | length of stay | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | total direct medical cost | hosp DC, 6 wks, 3, 6 and 9 months | No | |
Secondary | major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations) | hosp DC, 6 wks, 3, 6 and 9 months | No |
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