Contrast Nephropathy and Nitrates

Completed · Phase 4 · Has a placebo group

Conditions studied: Contrast Induced Nephropathy

In brief

Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is used during coronary angiography to see the coronary arteries. It has been shown that exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some high risk patients it progresses into renal failure. This research study offers a new possible option to prevent CIN. We propose that if intravenous nitroglycerin is given before the procedure it may lower the chances of developing contrast-induced nephropathy.

Key facts

Study ID: NCT01999517
Run by: Mt. Sinai Medical Center, Miami
People needed: 122
Starts: 2013-06-01
Expected to finish: 2018-06-01
Last updated by the study team: 2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be scheduled for percutaneous coronary angiography.
Patients must have a Mehran score more or equal to 6 before the procedure.
Patients must have baseline creatinine and hemoblogin drawn before the procedure.
Signed informed consent.

You may not qualify if…

Patients on renal replacement therapy before randomization, will be excluded.
Being exposed to any types of nitrates 48 hours prior to randomization,
History of allergic reaction to any of the components of intravenous nitroglycerin.
Exposure to contrast media 4 days prior randomization.
Planned revascularization in the next 24 to 48 hours of the first PCI procedure.
The patient is hypotensive (<90/60mmHg) at the time of randomization.

Where it is running

Mount Sinai Medical Center — Miami Beach, Florida, United States

Full record on ClinicalTrials.gov

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