NITRATE-OCT-CIN (Sub-Study of NITRATE-OCT) (NCT05544981) | Clinical Trial Compass
CompletedNot Applicable
NITRATE-OCT-CIN (Sub-Study of NITRATE-OCT)
United Kingdom300 participantsStarted 2016-01-02
Plain-language summary
The NITRATE-OCT:- Contrast Nephropathy Sub-study is a proof-of concept single center, randomized, clinical trial designed to ascertain whether a dietary NO3- approach might prove useful adjunctive therapy improving renal function and reducing CIN in patients with stable angina undergoing elective angioplasty.
Objectives: To determine whether dietary NO3- ingestion exerts any effect on the glomerular filtration rate (GFR) after the exposure to contrast media.
To determine if dietary NO3- ingestion will decrease the incidence of contrast induced nephropathy.
Setting: The patients will be recruited from an on-going clinical trial NITRATE-OCT. This is a study assessing whether the use of dietary NO3- may reduce the incidence of restenosis following elective angioplasty. This study is recruiting patients with stable angina and single/multiple coronary artery stenosis undergoing elective PCI who are haemodynamically stable (systolic BP\>100 mmHg). These patients will be recruited at The Barts Heart Centre at St Bartholomew's Hospital. This is one of the biggest centres in the UK, serving a population of almost two million people from The City of London and The North East up to the M25 and is a 24/7 centre performing approximately 3000 angioplasties a year.
The study will take place in the Clinical Trials Unit, William Harvey Heart Centre.
Target population: A total of 246 patients (male and female, age 18-85) with stable angina as per requirements indicated above. Follow-up will take place in the Clinical Trials Unit, William Harvey Research Institute.
Treatment: Patients will be randomised (using an on line randomisation database) to receive 70 ml of a beetroot juice concentrate containing 4-5 mmol nitrate or nitrate-depleted placebo juice concentrate. This intervention will be taken by the patient daily from one day prior to re-establishment of flow with PCI and stent implantation.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with stable angina diagnosed by a cardiologist on optimal medical therapy undergoing angioplasty to treat residual symptoms.
. Aged 18-85
. Patients able and willing to give their written informed consent.
. Patients undergoing successful PCI procedure.
Exclusion criteria
. Unstable ischaemic heart disease, with an episode of chest pain in less than 24 hours.
. Patients who have had previous coronary artery bypass surgery (CABG), if they are undergoing angioplasty within a non-native vessel.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients undergoing angioplasty with a bio-absorbable stent.
. Current diagnosis of or treatment for malignancy, other than non-melanoma skin cancer.
. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
. Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
. Severe acute infection, or significant trauma (burns, fractures).