NCT01999517

Contrast Nephropathy and Nitrates

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contrast Induced Nephropathy

Interventions

Type	Name	Description
DRUG	Intravenous Nitroglycerin
DRUG	IV Fluids

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2013-12-03
• Last updated: 2019-10-29
• Results posted: 2019-10-29

Locations

1 site across 1 country: United States