Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery

This study has been completed.
Sponsor:
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: September 10, 2014
Last verified: September 2014
  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 ]

Enrollment: 18876
Study Start Date: April 2006
Study Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549796

  Show 60 Study Locations
Sponsors and Collaborators
Johns Hopkins University
Duke University
Maryland Medical Research Institute
Investigators
Study Director: Thomas Aversano, MD Johns Hopkins University
  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: September 10, 2014
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:
Arteriosclerosis
Atherosclerosis
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Chest Pain
Pain
Signs and Symptoms
Coronary Disease

ClinicalTrials.gov processed this record on September 16, 2014