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NCT01999517 · ClinicalTrials.gov registry record · Phase 4
Contrast Nephropathy and Nitrates
A Phase 4 study of Contrast Induced Nephropathy, sponsored by Mt. Sinai Medical Center, Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 122
- Enrollment target
- 1
- Study location
NCT01999517: Completed Phase 4 study of Contrast Induced Nephropathy, sponsored by Mt. Sinai Medical Center, Miami.
NCT01999517 is a Phase 4 study of Contrast Induced Nephropathy that has completed, run by Mt. Sinai Medical Center, Miami. The registered enrollment target is 122 participants, below the 245-participant average among 3 other Contrast Induced Nephropathy trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999517, a Phase 4 study of Contrast Induced Nephropathy, has completed, sponsored by Mt. Sinai Medical Center, Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 122 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Intravenous Nitroglycerin
- DRUG IV Fluids
Study Locations (1)
Florida
- Mount Sinai Medical Center - Miami Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2013-06 |
| Est. Completion | 2018-06 |
| Phase | Phase 4 |
What the finished NCT01999517 record still lists
NCT01999517 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 245-participant average among 3 other Contrast Induced Nephropathy trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Contrast Induced Nephropathy appearing as the primary indexed condition, and to 2 interventions - of which Intravenous Nitroglycerin is the first listed.
NCT01999517 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01999517 about?
NCT01999517 is a clinical study titled "Contrast Nephropathy and Nitrates". 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...
What is the current status of trial NCT01999517?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 122 participants. The study started on 2013-06. Estimated completion is 2018-06.
What conditions does trial NCT01999517 study?
This clinical trial studies the following conditions: Contrast Induced Nephropathy.
What interventions are being tested in trial NCT01999517?
The interventions under investigation include: Intravenous Nitroglycerin (DRUG), IV Fluids (DRUG).
Who is sponsoring clinical trial NCT01999517?
This trial is sponsored by Mt. Sinai Medical Center, Miami, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01999517 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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