Prevention of Serious Adverse Events Following Angiography



Status:Completed
Conditions:Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:February 7, 2013
End Date:October 17, 2017

Use our guide to learn which trials are right for you!

CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
35
sites
San Francisco, California 94121
Phone: 415-750-2076
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48113
Phone: 734-845-5531
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Augusta, Georgia 30904
Phone: 706-823-3902
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Bay Pines, Florida 33708
Phone: 727-398-6661
?
mi
from
Bay Pines, FL
Click here to add this to my saved trials
Buffalo, New York 14215
Phone: 716-834-9200
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Charleston, South Carolina 29401
Phone: 843-789-7594
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60612
Phone: 312-996-6730
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45220
Phone: 513-861-3100
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
Phone: 216-791-3800
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45428
Phone: 937-262-2113
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
Phone: 404-329-2207
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-794-7300
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Phone: 317-988-2093
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Missouri 64128
Phone: 816-861-4700
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Memphis, Tennessee 38104
Phone: 901-523-8990
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Minneapolis, Minnesota 55417
Phone: 612-725-2000
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10010
Phone: 212-951-3335
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Phone: 405-456-5378
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palo Alto, California 94304
Phone: 650-858-3932
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15240
Phone: 412-360-3911
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97201
Phone: 503-220-8262
?
mi
from
Portland, OR
Click here to add this to my saved trials
Richmond, Virginia 23249
Phone: 804-675-5448
?
mi
from
Richmond, VA
Click here to add this to my saved trials
915 North Grand Boulevard
Saint Louis, Missouri 63106
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salem, Virginia 24153
Phone: 540-982-2463
?
mi
from
Salem, VA
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98108
Phone: 206-764-2512
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tucson, Arizona 85723
Phone: 520-792-1450
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
West Los Angeles, California 90073
Phone: 310-268-4695
?
mi
from
West Los Angeles, CA
Click here to add this to my saved trials
West Roxbury, Massachusetts 02132
Phone: 857-203-5550
?
mi
from
West Roxbury, MA
Click here to add this to my saved trials