CoNaN: Contrast Nephropathy and Nitrates

• Sponsor: Mt. Sinai Medical Center, Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT01999517
• Collaborator: Florida Heart Research Institute (Other)
• Enrollment: 122
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Drug: Intravenous Nitroglycerin; Drug: IV Fluids	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Contrast Nephropathy and Nitrates
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravenous Nitroglycerin IV Nitroglycerin with IV Fluids	Drug: Intravenous Nitroglycerin; Drug: IV Fluids
Placebo Comparator: Placebo IV Fluids	Drug: IV Fluids

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140

Sponsors and Collaborators

• Mt. Sinai Medical Center, Miami
• Florida Heart Research Institute

Investigators

• Principal Investigator: Gervasio Lamas, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 14, 2015

More Information

Publications

None provided.

• Responsible Party: Gervasio Lamas, MD, Chied of Medicine, Chair of Cardiology, Mt. Sinai Medical Center, Miami
• ClinicalTrials.gov Identifier: NCT01999517
• Other Study ID Numbers: ConanTrial
• First Posted: Dec 3, 2013
• Last Update Posted: Oct 29, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Kidney Diseases; Nitroglycerin

Study Results

Participant Flow

Arm/Group Title	Intravenous Nitroglycerin	Placebo
Arm/Group Description	Intravenous Nitroglycerin with IV Fluids	IV Fluids
Period Title: Overall Study
STARTED	68	54
COMPLETED	68	54
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intravenous Nitroglycerin	Placebo	Total
Arm/Group Description	Intravenous Nitroglycerin with IV Fluids	IV Fluids	Total of all reporting groups
Overall Participants	68	54	122
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	77	76	76
Sex: Female, Male (Count of Participants)
Female	16 23.5%	16 29.6%	32 26.2%
Male	52 76.5%	38 70.4%	90 73.8%
Race/Ethnicity, Customized (Count of Participants)
White	26 38.2%	21 38.9%	47 38.5%
Black	5 7.4%	3 5.6%	8 6.6%
Asian	2 2.9%	2 3.7%	4 3.3%
Hispanic	34 50%	27 50%	61 50%
Unknown/not reported	1 1.5%	1 1.9%	2 1.6%
Region of Enrollment (Count of Participants)
United States	68 100%	54 100%	122 100%
eGFR (Baseline) (mL/min) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mL/min]	58.3	59.1	58.6

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Nitroglycerin	Placebo
Arm/Group Description	IV Nitroglycerin with IV Fluids Intravenous Nitroglycerin IV Fluids	IV Fluids IV Fluids
Measure Participants	68	54
Median (Inter-Quartile Range) [mL/min]	1.8	-4.1

Adverse Events

Time Frame	4 years
Adverse Event Reporting Description	The collection of adverse events does not differ from the clinicaltrials.gov definitions.
Arm/Group Title	Intravenous Nitroglycerin		Placebo
Arm/Group Description	Intravenous Nitroglycerin with IV Fluids		IV Fluids
All Cause Mortality
	Intravenous Nitroglycerin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/54 (0%)
Serious Adverse Events
	Intravenous Nitroglycerin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	Intravenous Nitroglycerin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/68 (5.9%)		2/54 (3.7%)
Cardiac disorders
Hypotension	4/68 (5.9%)	4	2/54 (3.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.