Prevention of Serious Adverse Events Following Angiography

(PRESERVE Trial)

Recruiting in Palo Alto (17 mi)

+53 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Steven D. Weisbord, MD MSc

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

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

Treatment Details

Interventions

• IV isotonic bicarbonate (Electrolyte Supplement)
• IV isotonic saline (Electrolyte Supplement)
• N-acetylcysteine (Mucolytic Agent)
• Placebo (Placebo)

Participant Groups

Group I: Saline & oral placebo Active Control 2 Interventions

IV isotonic saline and oral placebo drug capsule

Group II: Saline & oral N-acetylcysteine Active Control 2 Interventions

IV isotonic saline and oral N-acetylcysteine drug capsule

Group III: Bicarbonate & oral N-acetylcysteine Active Control 2 Interventions

IV isotonic bicarbonate and oral N-acetylcysteine drug capsule

Group IV: Bicarbonate & oral placebo Active Control 2 Interventions

IV isotonic bicarbonate and oral placebo drug capsule

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

The George Institute

Collaborator

Trials

84

Recruited

275,000+

Professor Anushka Patel

The George Institute

Chief Executive Officer since 2023

Medical training at the University of Queensland, postgraduate research degrees from Harvard University and University of Sydney

Dr. Patrizia Cavazzoni

The George Institute

Chief Medical Officer

MD from Harvard Medical School