Contrast Nephropathy and Nitrates

NCT01999517 | Completed Phase 4 Results DMC

• 1 other identifier: ConanTrial
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 48 to 72 hours post-PCI

Study Arms (2)

Intravenous Nitroglycerin

ACTIVE COMPARATOR

IV Nitroglycerin with IV Fluids

Drug: Intravenous Nitroglycerin; Drug: IV Fluids

Placebo

PLACEBO COMPARATOR

IV Fluids

Drug: IV Fluids

Interventions

Intravenous Nitroglycerin DRUG

Intravenous Nitroglycerin

IV Fluids DRUG

Intravenous Nitroglycerin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Gervasio Lamas, MD
• Organization: Mount Sinai Medical Center

gervasiolamas@gmail.com

305-674-2162

Study Officials

• Gervasio Lamas, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chied of Medicine, Chair of Cardiology

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 29, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-08

Locations

US (1)