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Prevention study for Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
Official title 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
ClinicalTrials.gov ID: NCT06984406
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
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
- 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...
You likely can't join if
- 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...
- Life-threatening conditions requiring emergency medical care.
- Participation in other clinical trials.
- Pregnancy, lactation.
See the full eligibility criteria
- 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...
- Signing informed consent.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
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 Moscow, Russia. 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.