Contrast Nephropathy and Nitrates (CoNaN)

Mt. Sinai Medical Center, Miami

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Nephropathy

Treatments: Drug: IV Fluids; Drug: Intravenous Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT01999517

ConanTrial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

Intravenous Nitroglycerin

Active Comparator group

Description:

IV Nitroglycerin with IV Fluids

Treatment:

Drug: Intravenous Nitroglycerin

Drug: IV Fluids

Placebo

Placebo Comparator group

Description:

IV Fluids

Treatment:

Drug: IV Fluids