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NCT Number: NCT00549796

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

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.

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Key information

Conditions

Coronary Arteriosclerosis Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crestwood Medical Center, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention (PCI)

Other

Patients undergo routine, clinically indicated PCI

Primary outcomes

  1. Mortality

    Time frame: 6 weeks

  2. MACE = death + MI + TVR

    Time frame: 9 Months

Secondary outcomes

  1. emergency CABG

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  2. myocardial infarction

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  3. target vessel revascularization (TVR)

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  4. any subsequent revascularization (ASR)

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  5. heart failure and class

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  6. angina and class

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  7. stroke

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  8. composite adverse endpoint (MACE)

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  9. MACE = death + MI + TVR

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  10. MACE = death + MI + ASR

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

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

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

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

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  13. completeness of revascularization

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  14. percent of patients with complete or partial revascularization

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

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

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  16. length of stay

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

  17. total direct medical cost

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

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

    Time frame: hosp DC, 6 wks, 3, 6 and 9 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Duke University
  • Maryland Medical Research Institute

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2007
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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