Coronary Artery Disease Clinical Trial
— PRESERVEOfficial title:
CSP #578 - Prevention of Serious Adverse Events Following Angiography (PRESERVE)
Verified date | September 2022 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5177 |
Est. completion date | October 17, 2017 |
Est. primary completion date | September 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Flinders Medical Centre | Bedford Park | South Australia |
Australia | Canberra Hospital | Canberra | Australian Capital Territory |
Australia | Concord Hospital | Concord | New South Wales |
Australia | Northern Health | Epping | Victoria |
Australia | Fremantle Hospital | Fremantle | Western Australia |
Australia | Gosford Hospital | Gosford | New South Wales |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Nepean Hospital | Kingswood | New South Wales |
Australia | St. George Hospital | Kogarah | New South Wales |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Royal Perth Hospital | Perth | Western Australia |
Australia | Royal North Shore Hospital | St. Leonards | New South Wales |
Malaysia | Penang Hospital | George Town | Penang |
Malaysia | University of Malaya Medical Center | Kuala Lumpur | |
Malaysia | Hospital Serdang | Sepang | Selangor |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Wellington Hospital | Newtown | Wellington |
New Zealand | Taranaki Base Hospital | Westown | New Plymouth |
United States | New Mexico VA Health Care System, Albuquerque, NM | Albuquerque | New Mexico |
United States | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan |
United States | Charlie Norwood VA Medical Center, Augusta, GA | Augusta | Georgia |
United States | Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines | Florida |
United States | VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York |
United States | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina |
United States | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois |
United States | Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio |
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
United States | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas |
United States | Dayton VA Medical Center, Dayton, OH | Dayton | Ohio |
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
United States | Durham VA Medical Center, Durham, NC | Durham | North Carolina |
United States | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
United States | Kansas City VA Medical Center, Kansas City, MO | Kansas City | Missouri |
United States | Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR | Little Rock | Arkansas |
United States | Memphis VA Medical Center, Memphis, TN | Memphis | Tennessee |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York |
United States | Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | Portland VA Medical Center, Portland, OR | Portland | Oregon |
United States | Hunter Holmes McGuire VA Medical Center, Richmond, VA | Richmond | Virginia |
United States | St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Saint Louis | Missouri |
United States | Salem VA Medical Center, Salem, VA | Salem | Virginia |
United States | VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah |
United States | South Texas Health Care System, San Antonio, TX | San Antonio | Texas |
United States | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California |
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
United States | Southern Arizona VA Health Care System, Tucson | Tucson | Arizona |
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
United States | VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA | West Roxbury | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | The George Institute |
United States, Australia, Malaysia, New Zealand,
Bullen AL, Cashion W, Webster L, Palevsky PM, Weisbord SD, Ix JH. Estimated Urinary Flow Rate and Contrast-Associated Acute Kidney Injury Risk: The PRESERVE (Prevention of Serious Adverse Events Following Angiography) Trial. Kidney Med. 2021 Feb 27;3(3):4 — View Citation
Garcia S, Bhatt DL, Gallagher M, Jneid H, Kaufman J, Palevsky PM, Wu H, Weisbord SD; PRESERVE Trial Group. Strategies to Reduce Acute Kidney Injury and Improve Clinical Outcomes Following Percutaneous Coronary Intervention: A Subgroup Analysis of the PRES — View Citation
Parikh CR, Liu C, Mor MK, Palevsky PM, Kaufman JS, Thiessen Philbrook H, Weisbord SD. Kidney Biomarkers of Injury and Repair as Predictors of Contrast-Associated AKI: A Substudy of the PRESERVE Trial. Am J Kidney Dis. 2020 Feb;75(2):187-194. doi: 10.1053/ — View Citation
Soomro QH, Anand ST, Weisbord SD, Gallagher MP, Ferguson RE, Palevsky PM, Bhatt DL, Parikh CR, Kaufman JS; PRESERVE Trial Investigators. The Relationship between Rate and Volume of Intravenous Fluid Administration and Kidney Outcomes after Angiography. Cl — View Citation
Weisbord SD, Palevsky PM, Kaufman JS, Wu H, Androsenko M, Ferguson RE, Parikh CR, Bhatt DL, Gallagher M; PRESERVE Trial Investigators. Contrast-Associated Acute Kidney Injury and Serious Adverse Outcomes Following Angiography. J Am Coll Cardiol. 2020 Mar — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride. | Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography. | Within 90 days following angiography | |
Primary | Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo. | Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography. | Within 90 days following angiography |
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