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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:
We hypothesize that the nitrate-based food product will significantly reduce the incidence of CIN compared to standard care. Additionally, we expect:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate Supplementation Group | Experimental | 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. |
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| Standard Care Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beet-Derived Inorganic Nitrate-Based Food Product | Dietary Supplement | This intervention consists of an orally administered food product enriched with inorganic nitrates derived from beetroot. Participants in the intervention group will consume a standardized dose of 12 mmol of nitrate per day for 5 days (starting 24 hours before PCI and continuing for 4 days post-procedure). The product is designed to enhance nitric oxide bioavailability, improve renal perfusion, reduce oxidative stress, and lower the risk of contrast-induced nephropathy (CIN). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Contrast-Induced Nephropathy (CIN) | Contrast-induced nephropathy (CIN) will be defined based on KDIGO criteria as:
| Baseline, 48 hours post-PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Renal Function Biomarkers (NGAL, Cystatin C, eGFR) | Neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin C will be measured at baseline, 4-6 hours, 24 hours, and 48-72 hours post-PCI to assess early kidney injury. Estimated glomerular filtration rate (eGFR) will be calculated at baseline, 48-72 hours, and 3 months post-PCI to evaluate long-term renal function changes. | Baseline, 4-6 hours, 24 hours, 48 hours, and 3 months post-PCI |
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Inclusion Criteria:
Age ≥18 years.
Planned PCI.
High risk of CIN with:
Signing informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Levshina | Contact | +79158559968 | levshina.ar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation | Recruiting | Moscow | Russia |
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| Incidence of Major Adverse Cardiovascular Events (MACE) | MACE will be defined as the composite of: Cardiovascular death Myocardial infarction Stroke Unplanned coronary revascularization The incidence will be compared between the two study arms. | 3 months and 12 months post-PCI |
| Quality of Life Assessment (EQ-5D Score) | Changes in quality of life will be assessed using the EQ-5D questionnaire, a validated tool measuring five dimensions: Mobility Self-care Usual activities Pain/discomfort Anxiety/depression Scores will be compared between groups to evaluate the impact of nitrate supplementation. | Baseline and 12 months post-PCI |
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