Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

Randomized Controlled Trial on the Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention (BEET-CIN Trial)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents. CIN is associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. Current preventive strategies include adequate hydration and minimizing contrast volume; however, there is no universally effective pharmacological intervention. Recent studies suggest that inorganic nitrates can enhance renal perfusion, reduce oxidative stress, and improve endothelial function, potentially lowering the risk of CIN. This study aims to evaluate the efficacy and safety of a beet-derived inorganic nitrate-based food product for the prevention of CIN in high-risk patients undergoing PCI. This is a randomized, controlled, open-label clinical trial comparing two groups: 1. Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI). 2. Control Group: Patients receiving standard medical care without additional nitrate supplementation. We hypothesize that the nitrate-based food product will significantly reduce the incidence of CIN compared to standard care. Additionally, we expect: 1. A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group. 2. A slower decline or even improvement in eGFR at follow-up. 3. A potential reduction in MACE due to the vasoprotective effects of nitrates. 4. Improved quality of life scores (EQ-5D) in the intervention group. If successful, this study will provide new evidence supporting the use of dietary nitrates for renal protection and may contribute to the development of novel, cost-effective prevention strategies for CIN.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• Planned PCI.

• High risk of CIN with:

‣ eGFR according to the CKD-EPI formula \<60 ml/min/1.73 m2 or

⁃ At least two of the following criteria: liver damage (cirrhosis), diabetes mellitus, age \>70 years, administration of contrast in the last 7 days, CHF (LVEF \>40%), intake of drugs affecting renal function (ACE inhibitors, ARBs, NSAIDs, aminoglycosides, diuretics).

• Signing informed consent.

Locations
Other Locations
Russian Federation
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
RECRUITING
Moscow
Contact Information
Primary
Ann Levshina
levshina.ar@gmail.com
+79158559968
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 88
Treatments
Experimental: Nitrate Supplementation Group
Participants in this arm will receive standard preventive measures for contrast-induced nephropathy, including adequate hydration and contrast volume minimization and in addition beet-derived inorganic nitrate-based food product as an oral supplement for 5 days. The intervention will start 24 hours before PCI and continue for 4 days post-procedure. The supplementation aims to enhance renal perfusion, reduce oxidative stress, and prevent contrast-induced nephropathy.
No_intervention: Standard Care Group
Participants in this arm will receive standard preventive measures for contrast-induced nephropathy, including adequate hydration and contrast volume minimization, but will not receive the nitrate-based supplement.
Sponsors
Leads: National Medical Research Center for Therapy and Preventive Medicine

This content was sourced from clinicaltrials.gov