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Contrast Nephropathy and Nitrates

Information source: Mt. Sinai Medical Center, Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contrast Induced Nephropathy

Intervention: Intravenous Nitroglycerin (Drug); IV Fluids (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mt. Sinai Medical Center, Miami

Official(s) and/or principal investigator(s):
Gervasio Lamas, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai

Overall contact:
Julio Peguero, MD, Email: Julio.Peguero@msmc.com


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.

Clinical Details

Official title: Contrast Nephropathy and Nitrates

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Change in GFR

Detailed description: The Contrast Nephropathy and Nitrates trial (CoNaN) is a single center, randomized, 1 x 1 factorial clinical trial designed to test the effects of intravenous nitroglycerin infusion in renal function given prior to PCI. Specific aims for this trial include:

- To determine whether the intravenous nitrates have any effect on the glomerular

filtration rate (GFR) after the exposure to contrast media.

- To determine if intravenous nitroglycerin will decrease the incidence of contrast

induced Nephropathy. 400 patients with a Mehran score of > 6 and a pre-procedural creatinine measurement will be enrolled. Following baseline assessments, patients will be randomly assigned to receive intravenous infusion nitroglycerine plus intravenous normal saline or normal saline only. Subjects will participate in this study from the time they sign consent (prior to angiographic procedure), until 48-72 hours post procedure.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Patient must be scheduled for percutaneous coronary angiography. 2. Patients must have a Mehran score more or equal to 6 before the procedure. 3. Patients must have baseline creatinine and hemoblogin drawn before the procedure. 4. Signed informed consent. Exclusion Criteria: 1. Patients on renal replacement therapy before randomization, will be excluded. 2. Being exposed to any types of nitrates 48 hours prior to randomization, 3. History of allergic reaction to any of the components of intravenous nitroglycerin. 4. Exposure to contrast media 4 days prior randomization. 5. Planned revascularization in the next 24 to 48 hours of the first PCI procedure. 6. The patient is hypotensive (<90/60mmHg) at the time of randomization.

Locations and Contacts

Julio Peguero, MD, Email: Julio.Peguero@msmc.com

Mount Sinai Medical Center, Miami Beach, Florida 33140, United States; Recruiting
Additional Information

Starting date: June 2013
Last updated: April 6, 2015

Page last updated: August 23, 2015

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