Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
This study is ongoing, but not recruiting participants.
Sponsor:
Johns Hopkins University
Collaborators:
Duke University
Maryland Medical Research Institute
Information provided by (Responsible Party):
Thomas Aversano, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00549796
First received: October 24, 2007
Last updated: March 28, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Arteriosclerosis Angina Pectoris |
Other: Percutaneous coronary intervention (PCI) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Mortality [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- MACE = death + MI + TVR [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- emergency CABG [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- myocardial infarction [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- target vessel revascularization (TVR) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- any subsequent revascularization (ASR) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- heart failure and class [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- angina and class [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- stroke [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- composite adverse endpoint (MACE) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- MACE = death + MI + TVR [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- MACE = death + MI + ASR [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- angiographic (end-procedure) complications (embolization, dissection, no reflow, etc) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- completeness of revascularization [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- percent of patients with complete or partial revascularization [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- bleeding (non-CABG transfusion, vascular repair) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
- length of stay [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- total direct medical cost [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
- major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18000 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
PCI performed at a hospital with co-located (on-site) cardiac surgery
|
Other: Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
|
|
2
PCI performed at a hospitals without co-located (on-site) cardiac surgery
|
Other: Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549796
Locations
| United States, Alabama | |
| Crestwood Medical Center | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Georgia | |
| Wellstar Cobb Hospital | |
| Austell, Georgia, United States | |
| Southeast Georgia Health System | |
| Brunswick, Georgia, United States | |
| Tanner Medical Center | |
| Carrollton, Georgia, United States | |
| Hamilton Medical Center | |
| Dalton, Georgia, United States, 30722 | |
| Fairview Park Hospital | |
| Dublin, Georgia, United States, 31021 | |
| Spalding Regional Medical Center | |
| Griffin, Georgia, United States | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States | |
| Archbold Memorial Hospital | |
| Thomasville, Georgia, United States, 31792 | |
| Tift Regional Medical Center | |
| Tifton, Georgia, United States | |
| United States, Illinois | |
| Little Company of Mary Hospital | |
| Evergreen Park, Illinois, United States | |
| Advocate South Suburban Hospital | |
| Hazel Crest, Illinois, United States, 60429 | |
| United States, New Jersey | |
| Bayonne Medical Center | |
| Bayonne, New Jersey, United States, 07002 | |
| Trinitas Hospital | |
| Elizabeth, New Jersey, United States | |
| Virtua-West Jersey Hospital Marlton | |
| Evesham, New Jersey, United States | |
| Robert Wood Johnson Medical Center | |
| Hamilton, New Jersey, United States | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States | |
| Raritan Bay Medical Center | |
| Perth Amboy, New Jersey, United States | |
| Somerset Medical Center | |
| Somerville, New Jersey, United States | |
| Muhlenberg Regional Medical Center | |
| South Plainfield, New Jersey, United States | |
| Holy Name Hospital | |
| Teaneck, New Jersey, United States | |
| United States, North Carolina | |
| Duke Health Raleigh Hospital | |
| Raleigh, North Carolina, United States, 27609 | |
| Rowan Regional Medical Center | |
| Salisbury, North Carolina, United States | |
| United States, Ohio | |
| Community Health and Wellness Center | |
| Bryan, Ohio, United States, 43506 | |
| Fort Hamilton Hospital | |
| Fort Hamilton, Ohio, United States | |
| Knox Community Hospital | |
| Mount Vernon, Ohio, United States | |
| Southern Ohio Medical Center | |
| Portsmouth, Ohio, United States | |
| United States, Oregon | |
| Legacy Meridian Park Hospital | |
| Portland, Oregon, United States | |
| United States, Texas | |
| Kingwood Medical Center | |
| Kingwood, Texas, United States | |
Sponsors and Collaborators
Johns Hopkins University
Duke University
Maryland Medical Research Institute
Investigators
| Study Director: | Thomas Aversano, MD | Johns Hopkins Medical Institutions |
More Information
No publications provided by Johns Hopkins University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Thomas Aversano, Associate Professor of Medicine, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00549796 History of Changes |
| Other Study ID Numbers: | NA_000230, C-PORT E Trial |
| Study First Received: | October 24, 2007 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
coronary artery disease angioplasty stent |
percutaneous coronary intervention on-site cardiac surgery randomized trial |
Additional relevant MeSH terms:
|
Angina Pectoris Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Arterial Occlusive Diseases Coronary Disease |
ClinicalTrials.gov processed this record on May 19, 2013