Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)BEET-CINNCT06984406
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
A study testing Beet-Derived Inorganic Nitrate-Based Food Product in people with Contrast-induced Nephropathy Following Percutaneous Intervention (CIN), run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
- What is being tested?
- Beet-Derived Inorganic Nitrate-Based Food Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Allergy to nitrates.
- Acute coronary syndrome.
- Acute condition accompanied by systolic blood pressure <90 mmHg for more th an 30 minutes or requiring the use of drugs with a positive inotropic effect.
- Life-threatening conditions requiring emergency medical care.
- Participation in other clinical trials.
- Pregnancy, lactation.
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- Use of nitrates in the last 30 days.
- Abuse of alcohol, illegal drugs, mnestic-intellectual decline, as well as other reasons and circumstances indicating expected low adherence to treatment.
- Refusal to follow the plan of visits and examinations provided for by the protocol of this clinical trial.
- Refusal to sign informed consent.
- Infectious diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
Moscow
Ann Levshina, 89158559968, levshina.ar@gmail.com
About this study
Official title: 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)
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.
Read more
This is a randomized, controlled, open-label clinical trial comparing two groups:
- Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI).
- 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:
- A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group.
- A slower decline or even improvement in eGFR at follow-up.
- A potential reduction in MACE due to the vasoprotective effects of nitrates.
- 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.
- Being tested
- Beet-Derived Inorganic Nitrate-Based Food Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet-Derived Inorganic Nitrate-Based Food ProductDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Beet-Derived Inorganic Nitrate-Based Food Product |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast-Induced Nephropathy (CIN)
Contrast-induced nephropathy (CIN) will be defined based on KDIGO criteria as:
- An increase in serum creatinine of ≥0.3 mg/dL (26.52 μmol/L) within 48 hours post-PCI, OR
- An increase in serum creatinine of ≥1.5 times from baseline within 7 days post-PCI.
- A urine output < 0.5 mL/kg/hour for six hours. The incidence of CIN will be compared between the intervention (nitrate supplementation) and control groups.
Measured: Baseline, 48 hours post-PCI
Secondary outcomes (3)
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.
Measured: Baseline, 4-6 hours, 24 hours, 48 hours, and 3 months post-PCI
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.
Measured: 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.
Measured: Baseline and 12 months post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984406
- Sponsor's protocol ID
- 02-02/25
- Acronym
- BEET-CIN
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06984406
- Acronym / sponsor ID
- BEET-CIN / 02-02/25
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI).
- 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:
- A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group.
- A slower decline or even improvement in eGFR at follow-up.
- A potential reduction in MACE due to the vasoprotective effects of nitrates.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate Supplementation Group | Experimental | Dietary Supplement: Beet-Derived Inorganic Nitrate-Based Food ProductParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Planned PCI.
- High risk of CIN with:
- Signing informed consent.
Key exclusion criteria (11 listed)
- Allergy to nitrates.
- Acute coronary syndrome.
- Acute condition accompanied by systolic blood pressure <90 mmHg for more th an 30 minutes or requiring the use of drugs with a positive inotropic effect.
- Life-threatening conditions requiring emergency medical care.
- Participation in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beet-Derived Inorganic Nitrate-Based Food ProductThis 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). | Dietary supplement | Nitrate Supplementation Group |
Primary outcome
Incidence of Contrast-Induced Nephropathy (CIN)
Time frame: Baseline, 48 hours post-PCI
Contrast-induced nephropathy (CIN) will be defined based on KDIGO criteria as: * An increase in serum creatinine of ≥0.3 mg/dL (26.52 μmol/L) within 48 hours post-PCI, OR * An increase in serum creatinine of ≥1.5 times from baseline within 7 days post-PCI. * A urine output < 0.5 mL/kg/hour for six hours. The incidence of CIN will be compared between the intervention (nitrate supplementation) and control groups.
3 secondary outcomes
Changes in Renal Function Biomarkers (NGAL, Cystatin C, eGFR)
Time frame: Baseline, 4-6 hours, 24 hours, 48 hours, and 3 months post-PCI
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 3 months and 12 months post-PCI
Quality of Life Assessment (EQ-5D Score)
Time frame: Baseline and 12 months post-PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet-Derived Inorganic Nitrate-Based Food Product in people with Contrast-induced Nephropathy Following Percutaneous Intervention (CIN), run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Levshina (+79158559968, levshina.ar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Contrast-Induced Nephropathy (CIN) (time frame: Baseline, 48 hours post-PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.