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| Name | Class |
|---|---|
| Florida Heart Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Nitroglycerin | Active Comparator | IV Nitroglycerin with IV Fluids |
|
| Placebo | Placebo Comparator | IV Fluids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Nitroglycerin | Drug |
| ||
| IV Fluids |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gervasio Lamas, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Nitroglycerin | Intravenous Nitroglycerin with IV Fluids |
| FG001 | Placebo | IV Fluids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
122 patients consented for participation, met all inclusion/exclusion criteria and were analyzed in the intention-to-treat protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Nitroglycerin | Intravenous Nitroglycerin with IV Fluids |
| BG001 | Placebo | IV Fluids |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | mL/min | Baseline and 48 to 72 hours post-PCI |
|
4 years
The collection of adverse events does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Nitroglycerin | Intravenous Nitroglycerin with IV Fluids | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gervasio Lamas, MD | Mount Sinai Medical Center | 305-674-2162 | gervasiolamas@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2015 | Aug 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| eGFR (Baseline) | estimated Glomerular Filtration Rate | Median | Inter-Quartile Range | mL/min |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 68 |
| 0 |
| 68 |
| 4 |
| 68 |
| EG001 | Placebo | IV Fluids | 0 | 54 | 0 | 54 | 2 | 54 |
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