For Healthcare Professionals

The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy

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About the study

Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality following coronary angiographic procedures in high-risk patients. Despite preventative measures intended to mitigate the risk of CIN, there remains a need for an effective intervention. Dietary inorganic nitrate therapy, which through its chemical reduction in the body delivers nitric oxide has shown promise in attenuating CIN, but its effectiveness in preserving long-term renal function is unknown.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Patients undergoing coronary angiography+/-Percutaneous Coronary Intervention (PCI) for NSTE-ACS
  2. Requirement for CIN prophylaxis as per Barts Heart Centre Criteria for CIN prophylaxis: eGFR<60ml/min OR 2 of the following: diabetes, liver failure (cirrhosis), age > 70yr, exposure to contrast in last 7 days, heart failure (or LVEF<40%), concomitant renally active drugs (ACEi, ARB, NSAIDs, aminoglycosides, diuretics)
  3. Aged >18
  4. Patients able and willing to give their written informed consent.

EXCLUSION CRITERIA

  1. ST segment myocardial infarction undergoing Primary PCI.
  2. Patients with eGFR<30ml/min or on renal replacement therapy
  3. Subjects presenting with cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation
  4. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
  5. 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.
  6. 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).
  7. Severe acute infection
  8. Pregnancy
  9. Breast-feeding mothers.
  10. Any Inclusion Criteria not met
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 020 7882 8377Email iconEmail Study Center

Study’s details


Contition

Acute Coronary Syndrome,Acute Kidney Injury,Contrast-induced Nephropathy

Age

18+

Phase

Phase 2

Participants needed

640

Est. Completion Date

Oct 2021

Treatment type

Interventional


Sponsor

Barts & The London NHS Trust

ClinicalTrials.gov identifier

NCT03627130

Study number

181

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