Contrast Nephropathy and Nitrates

Phase 4

Completed

• Conditions: Contrast Induced Nephropathy
• Interventions: Drug: Intravenous Nitroglycerin; Drug: IV Fluids

• Registration Number: NCT01999517
• Lead Sponsor: Mt. Sinai Medical Center, Miami

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2019-08
• Results First Submitted: 2019-08-13
• Results First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Results First Posted: 2019-10-29
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Nitroglycerin	Intravenous Nitroglycerin	IV Nitroglycerin with IV Fluids
Intravenous Nitroglycerin	IV Fluids	IV Nitroglycerin with IV Fluids
Placebo	IV Fluids	IV Fluids

Primary Outcome Measures

Name	Time	Method
Change in GFR	Baseline and 48 to 72 hours post-PCI	The primary endpoint for this trial will be to determine the change in glomerular filtration rate after exposure to contrast media. We will compare the change in GFR before and after PCI of the group that received intravenous nitroglycerin with the change in GFR before and after PCI of the group that did not receive intravenous nitroglycerin.

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States