Prevention of Serious Adverse Events Following Angiography

Last updated: October 15, 2025
Sponsor: VA Office of Research and Development
Overall Status: Completed

Phase

3

Condition

Chest Pain

Focal Segmental Glomerulosclerosis

Thrombosis

Treatment

N-acetylcysteine

IV isotonic bicarbonate

Placebo

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-angiographyeGFR <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 angiographydefined by 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 hoursbetween the identification of the indication for angiography and the time of theplanned procedure.

  • 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
Treatment Group(s): 4
Primary Treatment: N-acetylcysteine
Phase: 3
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

  • Canberra Hospital

    Canberra 2172517, Australian Capital Territory 2177478 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

  • Concord Hospital

    Concord 2170852, New South Wales 2155400 2139
    Australia

    Site Not Available

  • Gosford Hospital

    Gosford 2164849, New South Wales 2155400 2250
    Australia

    Site Not Available

  • Nepean Hospital

    Kingswood 2161303, New South Wales 2155400 2747
    Australia

    Site Not Available

  • St. George Hospital

    Kogarah 2161185, New South Wales 2155400 2217
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards 8029783, New South Wales 2155400 2065
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park 2076918, South Australia 2061327 5042
    Australia

    Site Not Available

  • Northern Health

    Epping, Victoria 3076
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Northern Health

    Epping 2167279, Victoria 2145234 3076
    Australia

    Site Not Available

  • Austin Health

    Heidelberg 2163654, Victoria 2145234 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

  • Fremantle Hospital

    Fremantle 2071223, Western Australia 2058645 6160
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth 2063523, Western Australia 2058645 6000
    Australia

    Site Not Available

  • University of Malaya Medical Center

    Kuala Lumpur 1735161, Kuala Lumpur 1733046 50603
    Malaysia

    Site Not Available

  • Penang Hospital

    George Town, Penang 10990
    Malaysia

    Site Not Available

  • Penang Hospital

    George Town 1735106, Pulau Pinang 1733047 10990
    Malaysia

    Site Not Available

  • Hospital Serdang

    Sepang, Selangor 43300
    Malaysia

    Site Not Available

  • Hospital Serdang

    Sepang 1734821, Selangor 1733037 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

  • Auckland City Hospital

    Auckland 2193733, Auckland 2193734 1142
    New Zealand

    Site Not Available

  • Taranaki Base Hospital

    Westown, New Plymouth 4310
    New Zealand

    Site Not Available

  • Taranaki Base Hospital

    Westown 6222897, 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

  • Wellington Hospital

    Newtown 6244789, Wellington Region 2179538 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

  • Southern Arizona VA Health Care System, Tucson

    Tucson 5318313, Arizona 5551752 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

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

    Little Rock 4119403, Arkansas 4099753 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

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

    Palo Alto 5380748, California 5332921 94304-1290
    United States

    Site Not Available

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco 5391959, California 5332921 94121
    United States

    Site Not Available

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

    West Los Angeles 5408115, California 5332921 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

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines 4146855, Florida 4155751 33708
    United States

    Site Not Available

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

    Gainesville 4156404, Florida 4155751 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

  • Charlie Norwood VA Medical Center, Augusta, GA

    Augusta 4180531, Georgia 4197000 30904
    United States

    Site Not Available

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur 4191124, Georgia 4197000 30033
    United States

    Site Not Available

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

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

    Indianapolis, Indiana 46202-2884
    United States

    Site Not Available

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

    Indianapolis 4259418, Indiana 4921868 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 Boston Healthcare System West Roxbury Campus, West Roxbury, MA

    West Roxbury 4955128, Massachusetts 6254926 02132
    United States

    Site Not Available

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan 48113
    United States

    Site Not Available

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor 4984247, Michigan 5001836 48113
    United States

    Site Not Available

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis 5037649, Minnesota 5037779 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

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City 4393217, Missouri 4398678 64128
    United States

    Site Not Available

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

    St Louis 4407066, Missouri 4398678 63106
    United States

    Site Not Available

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico 87108-5153
    United States

    Site Not Available

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque 5454711, New Mexico 5481136 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

  • VA Western New York Healthcare System, Buffalo, NY

    Buffalo 5110629, New York 5128638 14215
    United States

    Site Not Available

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

    New York 5128581, New York 5128638 10010
    United States

    Site Not Available

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Durham VA Medical Center, Durham, NC

    Durham 4464368, North Carolina 4482348 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

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati 4508722, Ohio 5165418 45220
    United States

    Site Not Available

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Dayton VA Medical Center, Dayton, OH

    Dayton 4509884, Ohio 5165418 45428
    United States

    Site Not Available

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Portland VA Medical Center, Portland, OR

    Portland, Oregon 97201
    United States

    Site Not Available

  • Portland VA Medical Center, Portland, OR

    Portland 5746545, Oregon 5744337 97201
    United States

    Site Not Available

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

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

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

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

    Pittsburgh 5206379, Pennsylvania 6254927 15240
    United States

    Site Not Available

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

    Charleston, South Carolina 29401-5799
    United States

    Site Not Available

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

    Charleston 4574324, South Carolina 4597040 29401-5799
    United States

    Site Not Available

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Memphis VA Medical Center, Memphis, TN

    Memphis 4641239, Tennessee 4662168 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 North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas 4684888, Texas 4736286 75216
    United States

    Site Not Available

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

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • South Texas Health Care System, San Antonio, TX

    San Antonio 4726206, Texas 4736286 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

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

    Salt Lake City 5780993, Utah 5549030 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

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond 4781708, Virginia 6254928 23249
    United States

    Site Not Available

  • Salem VA Medical Center, Salem, VA

    Salem 4784112, Virginia 6254928 24153
    United States

    Site Not Available

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

    Seattle, Washington 98108
    United States

    Site Not Available

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

    Seattle 5809844, Washington 5815135 98108
    United States

    Site Not Available

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