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