NCT06695429 Supplementation With Beetroot Juice to Prevent Contrast Associated Nephropathy During Hospitalization for Acute Coronary Syndrome Without ST Elevation
| NCT ID | NCT06695429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital General Universitario Santa Lucia |
| Condition | Non ST Segment Elevation Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-10-07 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2024-10-07 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to compare the possible beneficial effect of beetroot juice supplementation versus the usual management during hospitalization to prevent contrast-induced nephropathy after cardiac catheterizations. The study includes patients diagnosed with non-ST elevation acute coronary syndrome with a possible indication for catheterism and high risk of kidney injury related to iodinated contrast. The intervention group will drink 500 mL (2 glasses daily, at breakfast and dinner) of beetroot juice added to the usual diet for 7 days or until hospital discharge and will receive the recommendation to maintain a diet rich in inorganic nitrates. The control group will receive the usual diet and recommendations. In both cases, other therapies will be prescribed to prevent contrast-induced nephropathy (hydration and statins) if there is no contraindication. Our hypothesis is that a compound present in beetroot juice, inorganic nitrates, can prevent the deterioration of kidney function related to contrast due to its vasodilatory effect, in addition to improving the subsequent prognosis of coronary heart disease due to its anti-inflammatory and antiproliferative effects, protector of the endothelium and inhibitor of platelet aggregation. Beetroot juice could also be beneficial in this context due to the antioxidant effect of the betalains it contains.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Acute Coronary Syndrome without persistent ST segment elevation, with recommendation for invasive management according to the actual Clinical practice guidelines * At least moderate or high risk of nephropathy associated with iodinated contrast (Mehran score (without including contrast volume) ≥ 6). Exclusion Criteria: * \<18 years old or without capacity to give consent. * Refusal to participate in the study. * Known hypersensitivity to beetroot or any of its allergens. * Pregnant. * Inability to take food orally * Serious illnesses (not related to ACS or kidney failure), which limits their life expectancy to a period predictably less than 1 year. * On dialysis or predialysis at the time of inclusion. * ACS with persistent ST segment elevation before inclusion. * Shock or inotrope dependence at the time of inclusion * PCI already performed before inclusion. * Patients receiving intravenous nitroglycerin for \> 1 hour before inclusion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06695429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non ST Segment Elevation Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06695429 currently recruiting?
Yes, NCT06695429 is actively recruiting participants. Contact the research team at jmandreu@msn.com for enrollment information.
Where is the NCT06695429 trial being conducted?
This trial is being conducted at Cartagena, Spain.
Who is sponsoring the NCT06695429 clinical trial?
NCT06695429 is sponsored by Hospital General Universitario Santa Lucia. The trial plans to enroll 130 participants.