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Coronary ArteriosclerosisNCT00549796

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

A study testing Percutaneous coronary intervention (PCI) in people with Coronary Arteriosclerosis and Angina Pectoris, run by Johns Hopkins University at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Arteriosclerosis, Angina Pectoris
What is being tested?
Percutaneous coronary intervention (PCI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,876 participants
Where
60 sitesUnited States
Study dates
Apr 2006to Feb 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Sacred Heart Hospital

    Allentown, Pennsylvania

  • Anne Arundel Medical Center

    Annapolis, Maryland

  • Wellstar Cobb Hospital

    Austell, Georgia

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland

  • St. Agnes Hospital

    Baltimore, Maryland

  • Bayonne Medical Center

    Bayonne, New Jersey, 07002

  • Clara Maas Medical Center

    Belleville, New Jersey

  • Southeast Georgia Health System

    Brunswick, Georgia

  • Community Health and Wellness Center

    Bryan, Ohio, 43506

  • Tanner Medical Center

    Carrollton, Georgia

  • Chambersburg Hospital

    Chambersburg, Pennsylvania

  • University Hospitals Case Medical Center / Geauga Medical Center

    Chardon, Ohio

  • Southern Maryland Hospital Center

    Clinton, Maryland

  • University Hospital East Ohio State University Medical Center

    Columbus, Ohio

  • Hamilton Medical Center

    Dalton, Georgia, 30722

  • Southview Medical Center

    Dayton, Ohio

  • Fairview Park Hospital

    Dublin, Georgia, 31021

  • JFK Medical Center

    Edison, New Jersey

  • Trinitas Hospital

    Elizabeth, New Jersey

  • Little Company of Mary Hospital

    Evergreen Park, Illinois

  • Frederick Memorial Hospital

    Frederick, Maryland

  • Baltimore Washington Medical Center

    Glen Burnie, Maryland

  • Spalding Regional Medical Center

    Griffin, Georgia

  • Meritus Medical Center

    Hagerstown, Maryland

  • Robert Wood Johnson Medical Center

    Hamilton, New Jersey

  • Fort Hamilton Hospital

    Hamilton, Ohio

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Crestwood Medical Center

    Huntsville, Alabama, 35801

  • Kingwood Medical Center

    Kingwood, Texas

  • Armstrong County Memorial Hospital

    Kittanning, Pennsylvania

  • West Georgia Health

    La Grange, Georgia

  • Evangelical Community Hospital

    Lewisburg, Pennsylvania

  • Monmouth Medical Center

    Long Branch, New Jersey

  • Marietta Memorial Hospital

    Marietta, Ohio

  • Virtua-West Jersey Hospital Marlton

    Marlton, New Jersey

  • UPMC McKeesport

    McKeesport, Pennsylvania

  • Meadville Medical Center

    Meadville, Pennsylvania

  • Monongahela Valley Hospital

    Monongahela, Pennsylvania

  • Knox Community Hospital

    Mount Vernon, Ohio

  • Licking Memorial Hospital

    Newark, Ohio

  • Raritan Bay Medical Center

    Perth Amboy, New Jersey

  • Legacy Meridian Park Hospital

    Portland, Oregon

  • Southern Ohio Medical Center

    Portsmouth, Ohio

  • Duke Health Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Riverview Medical Center

    Red Bank, New Jersey

  • Southern Regional Medical Center

    Riverdale, Georgia

  • Shady Grove Adventist Hospital

    Rockville, Maryland

  • Rowan Regional Medical Center

    Salisbury, North Carolina

  • Holy Cross Hospital

    Silver Spring, Maryland

  • Somerset Medical Center

    Somerville, New Jersey

  • Muhlenberg Regional Medical Center

    South Plainfield, New Jersey

  • Overlook Medical Center

    Summit, New Jersey

  • Holy Name Hospital

    Teaneck, New Jersey

  • Mainland Medical Center

    Texas City, Texas

  • Archbold Memorial Hospital

    Thomasville, Georgia, 31792

  • Tift Regional Medical Center

    Tifton, Georgia

  • Community Medical Center

    Toms River, New Jersey

  • West Chester Hospital

    West Chester, Pennsylvania

  • Mt. Carmel St. Ann's Hospital

    Westerville, Ohio

  • Memorial Hospital

    York, Pennsylvania

Other trials in United States

About this study

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.

Read more

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.

Being tested
Percutaneous coronary intervention (PCI)
Keywords
coronary artery disease, angioplasty, stent, percutaneous coronary intervention, on-site cardiac surgery, randomized trial
Medical subject headings
Coronary Artery Disease, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary intervention (PCI)Other

    Patients undergo routine, clinically indicated PCI

Study groups in NCT00549796
Study groupRoleWhat they receive
1Active comparatorPCI performed at a hospital with co-located (on-site) cardiac surgery
Receives: Other: Percutaneous coronary intervention (PCI)
2OtherPCI performed at a hospitals without co-located (on-site) cardiac surgery
Receives: Other: Percutaneous coronary intervention (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 6 weeks

  2. MACE = death + MI + TVR

    Measured: 9 Months

Secondary outcomes (18)

  1. emergency CABG

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  2. myocardial infarction

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  3. target vessel revascularization (TVR)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  4. any subsequent revascularization (ASR)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  5. heart failure and class

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  6. angina and class

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  7. stroke

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  8. composite adverse endpoint (MACE)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  9. MACE = death + MI + TVR

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  10. MACE = death + MI + ASR

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  11. angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  12. angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  13. completeness of revascularization

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  14. percent of patients with complete or partial revascularization

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  15. bleeding (non-CABG transfusion, vascular repair)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  16. length of stay

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  17. total direct medical cost

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

  18. major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)

    Measured: hosp DC, 6 wks, 3, 6 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2007 (estimated)
  2. Study startApr 2006
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18,876 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00549796
Sponsor's protocol ID
NA_000230
Other IDs
C-PORT E Trial
Status last verified
Sep 2014
First submitted
24 Oct 2007
Last updated
11 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Hiremath PG, Aversano T, Spertus JA, Lemmon CC, Naiman DQ, Czarny MJ. Sex Differences in Health Status and Clinical Outcomes After Nonprimary Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Feb;15(2):e011308. doi: 10.1161/CIRCINTERVENTIONS.121.011308. Epub 2022 Jan 23.

    PubMed 35067071

  • Aversano T, Lemmon CC, Liu L; Atlantic CPORT Investigators. Outcomes of PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2012 May 10;366(19):1792-802. doi: 10.1056/NEJMoa1114540. Epub 2012 Mar 25.

    PubMed 22443460

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention (PCI) in people with Coronary Arteriosclerosis and Angina Pectoris, run by Johns Hopkins University at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00549796, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.

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