Prevention of Serious Adverse Events Following Angiography

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Renal Failure, Kidney Disease, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01467466

Run by

VA Office of Research and Development

People needed

5177

Starts

2013-10-07

Expected to finish

2017-10-17

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media in which it is anticipated that there will be an interval of 3 hours between the identification of the indication for angiography and the time of the planned 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

You may not qualify if…

• Stage 5 chronic kidney disease (CKD) (eGFR <15 mL/min/1.73 m2)
• Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low efficiency dialysis (SLED)
• Unstable baseline serum creatinine (SCr) (if known) at the time of angiography defined 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 of angiography:
• IV milrinone, amrinone, dobutamine, or nesiritide
• Isolated ultrafiltration therapy
• Intra-aortic balloon pump
• Emergent angiography procedures defined as an anticipated duration of <3 hours between the identification of the indication for angiography and the time of the planned 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

Where it is running

• Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR — Little Rock, Arkansas, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
• Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• Charlie Norwood VA Medical Center, Augusta, GA — Augusta, Georgia, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States
• VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA — West Roxbury, Massachusetts, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• Kansas City VA Medical Center, Kansas City, MO — Kansas City, Missouri, United States
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States
• Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY — New York, New York, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Dayton VA Medical Center, Dayton, OH — Dayton, Ohio, United States
• Oklahoma City VA Medical Center, Oklahoma City, OK — Oklahoma City, Oklahoma, United States
• Portland VA Medical Center, Portland, OR — Portland, Oregon, United States
• Southern Arizona VA Health Care System, Tucson — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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