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Completed

NCT Number: NCT01999517

Contrast Nephropathy and Nitrates

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intravenous Nitroglycerin

Drug

IV Fluids

Drug

Primary outcomes

  1. Change in GFR

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mt. Sinai Medical Center, Miami

Other

Collaborators

  • Florida Heart Research Institute

Registry information

Acronym: CoNaN

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2013
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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