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New treatment option for Ischemia Reperfusion Injury
Official title NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
ClinicalTrials.gov ID: NCT04750616
What this study is testing
What is Niacinamide?
Niacinamide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ischemia reperfusion injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent before any study-related activities.
- Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for...
- CABG
- Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement Risk factors for surgery related to adverse cardiovascular outcomes include...
You likely can't join if
- Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
- Kidney transplant status
- Off-pump cardiac surgery
- ESRD
- Emergent cardiac surgery
- Pregnancy
See the full eligibility criteria
- Informed consent before any study-related activities.
- Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes. Procedures include:
- CABG
- Aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following:
- Valve surgery
- eGFR \< 45 ml/min/1.73m2
- Documented LVEF ≤ 35% within six months before surgery
- Documented history of heart failure
- Insulin-requiring diabetes
- Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio)
- Preoperative anemia (hemoglobin \<11g/dl for men and women)
- History of prior CABG
- Age ≥65
- Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)
- Kidney transplant status
- Off-pump cardiac surgery
- ESRD
- Emergent cardiac surgery
- Pregnancy
- Patient enrolled in competing research studies that may affect outcomes
- Patients held in an institution by legal or official order
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.