Contrast Nephropathy and Nitrates (CoNaN)
Primary Purpose
Contrast Induced Nephropathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous Nitroglycerin
IV Fluids
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy
Eligibility Criteria
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.
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intravenous Nitroglycerin
Placebo
Arm Description
IV Nitroglycerin with IV Fluids
IV Fluids
Outcomes
Primary Outcome Measures
Change in GFR
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01999517
First Posted
November 26, 2013
Last Updated
October 11, 2019
Sponsor
Mt. Sinai Medical Center, Miami
Collaborators
Florida Heart Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01999517
Brief Title
Contrast Nephropathy and Nitrates
Acronym
CoNaN
Official Title
Contrast Nephropathy and Nitrates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mt. Sinai Medical Center, Miami
Collaborators
Florida Heart Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Nitroglycerin
Arm Type
Active Comparator
Arm Description
IV Nitroglycerin with IV Fluids
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV Fluids
Intervention Type
Drug
Intervention Name(s)
Intravenous Nitroglycerin
Intervention Type
Drug
Intervention Name(s)
IV Fluids
Primary Outcome Measure Information:
Title
Change in GFR
Description
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.
Time Frame
Baseline and 48 to 72 hours post-PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gervasio Lamas, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Contrast Nephropathy and Nitrates
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