Prevention of Serious Adverse Events Following Angiography

Last updated: September 21, 2022
Sponsor: VA Office of Research and Development
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Heart Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01467466
578
1011387
  • Ages > 18
  • All Genders

Study Summary

The purpose of this research study is to compare the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine (NAC) with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Planned elective or urgent coronary or non-coronary angiography with iodinatedcontrast media in which it is anticipated that there will be an interval of 3 hoursbetween the identification of the indication for angiography and the time of theplanned procedure.
  • Pre-angiography eGFR <60 ml/min/1.73 m2 with diabetes mellitus or pre-angiography eGFR <45 ml/min/1.73 m2 with or without diabetes mellitus
  • Ability to provide informed consent

Exclusion

Exclusion Criteria:

  • Stage 5 chronic kidney disease (CKD) (eGFR <15 mL/min/1.73 m2)
  • Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacementtherapy, or sustained low efficiency dialysis (SLED)
  • Unstable baseline serum creatinine (SCr) (if known) at the time of angiography definedby an increase in SCr of 25% over the 3 days prior to angiography
  • Decompensated heart failure requiring any of the following therapies at the time ofangiography:
  • IV milrinone, amrinone, dobutamine, or nesiritide
  • Isolated ultrafiltration therapy
  • Intra-aortic balloon pump
  • Emergent angiography procedures defined as an anticipated duration of <3 hours betweenthe identification of the indication for angiography and the time of the plannedprocedure.
  • Receipt of intravascular iodinated contrast within the 5 days preceding angiography
  • Receipt of oral or IV NAC within the 48 hours preceding angiography
  • Known allergy to N-acetylcysteine (NAC)
  • Known anaphylactic allergy to iodinated contrast media
  • Prisoner
  • Age <18 years
  • Pregnancy
  • Ongoing participation in an unapproved concurrent interventional study

Study Design

Total Participants: 5177
Study Start date:
October 07, 2013
Estimated Completion Date:
October 17, 2017

Study Description

The intravascular administration of iodinated contrast media for diagnostic imaging is a common cause of acute kidney injury (AKI) and a leading cause of iatrogenic renal disease. Contrast-induced AKI is associated with serious adverse outcomes including death, need for dialysis, prolonged hospitalization, and acceleration in the rate of progression of underlying chronic kidney disease. The benefit of IV isotonic bicarbonate compared to IV isotonic saline and of N-acetylcysteine for the prevention of contrast-induced AKI and associated adverse outcomes remains unclear. The purpose of this trial is to compare the effectiveness of IV isotonic sodium bicarbonate with IV isotonic sodium chloride and oral NAC with placebo for the prevention of serious adverse outcomes in 7,680 high-risk patients scheduled to undergo coronary or non-coronary angiography. Using a 2 x 2 factorial design, patients will be randomized to receive: 1) either peri-procedural IV isotonic sodium bicarbonate or peri-procedural IV isotonic saline and 2) either oral NAC or oral placebo prior to and for 5 days following the angiographic procedure. The primary study endpoint is a composite outcome comprised of death, need for acute dialysis, or persistent decline in kidney function within 90 days following the index angiogram.

Connect with a study center

  • Canberra Hospital

    Canberra, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Concord Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Gosford Hospital

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • St. George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St. Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Northern Health

    Epping, Victoria 3076
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Fremantle Hospital

    Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Penang Hospital

    George Town, Penang 10990
    Malaysia

    Site Not Available

  • Hospital Serdang

    Sepang, Selangor 43300
    Malaysia

    Site Not Available

  • Hospital Serdang

    Selangor, Serdang 43300
    Malaysia

    Site Not Available

  • University of Malaya Medical Center

    Kuala Lumpur, 50603
    Malaysia

    Site Not Available

  • Penang Hospital

    Penang, 10990
    Malaysia

    Site Not Available

  • Taranaki Base Hospital

    Westown, New Plymouth 4310
    New Zealand

    Site Not Available

  • Wellington Hospital

    Newtown, Wellington 1142
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington South, Wellington 1142
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland, 1142
    New Zealand

    Site Not Available

  • Southern Arizona VA Health Care System, Tucson

    Tucson, Arizona 85723
    United States

    Site Not Available

  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

    Little Rock, Arkansas 72205-5484
    United States

    Site Not Available

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California 94304-1290
    United States

    Site Not Available

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California 92161
    United States

    Site Not Available

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California 94121
    United States

    Site Not Available

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California 90073
    United States

    Site Not Available

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida 33708
    United States

    Site Not Available

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Charlie Norwood VA Medical Center, Augusta, GA

    Augusta, Georgia 30904
    United States

    Site Not Available

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana 46202-2884
    United States

    Site Not Available

  • VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA

    West Roxbury, Massachusetts 02132
    United States

    Site Not Available

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan 48113
    United States

    Site Not Available

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    Saint Louis, Missouri 63106
    United States

    Site Not Available

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    St Louis, Missouri 63106
    United States

    Site Not Available

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico 87108-5153
    United States

    Site Not Available

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo, New York 14215
    United States

    Site Not Available

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    New York, New York 10010
    United States

    Site Not Available

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dayton VA Medical Center, Dayton, OH

    Dayton, Ohio 45428
    United States

    Site Not Available

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Portland VA Medical Center, Portland, OR

    Portland, Oregon 97201
    United States

    Site Not Available

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina 29401-5799
    United States

    Site Not Available

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas 75216
    United States

    Site Not Available

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas 77030
    United States

    Site Not Available

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas 78229
    United States

    Site Not Available

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia 24153
    United States

    Site Not Available

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington 98108
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.