COOL RCN: Cooling to Prevent Radiocontrast Nephropathy
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|ClinicalTrials.gov Identifier: NCT00306306|
Recruitment Status : Terminated
First Posted : March 23, 2006
Last Update Posted : August 5, 2008
Radiographic contrast agents are administered to all patients undergoing diagnostic or interventional catheterization procedures. Injection of contrast enables visualization of the vasculature with X-ray based fluoroscopy or cineangiographic imaging. Unfortunately, the use of radiographic contrast agents is often associated with severe adverse side effects, including acute kidney failure. Acute kidney failure following exposure to an intravascular contrast agent is also known as Radiocontrast Nephropathy (RCN).
Physiologic factors that may put a patient at higher risk of developing RCN include: pre-existing renal insufficiency, diabetes mellitus, age, cardiovascular disease (particularly congestive heart failure and low ejection fraction), and dehydration or other conditions characterized by depletion of effective circulatory volume. These risk factors are relatively common in patients undergoing catheterization procedures. Treatment of high-risk patients can be modified, by hydration and/or minimizing contrast volume; however despite these efforts, RCN remains a well-recognized complication of coronary catheterization procedures.
Given the frequency and detrimental consequences of RCN, there is a compelling clinical need for safe and effective therapies to reduce the incidence of RCN. One such potential therapy is endovascular cooling to induce mild hypothermia. This study has been designed to evaluate whether endovascular cooling can reduce the incidence of RCN in high-risk patients who are undergoing diagnostic or interventional catheterization procedures.
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure Kidney Failure Renal Insufficiency||Device: Reprieve Endovascular Temperature Therapy System||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||COOL RCN: Cooling to Prevent Radiocontrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization|
|Study Start Date :||March 2006|
|Actual Study Completion Date :||August 2007|
- Incidence of RCN
- Equivalent safety profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306306
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Gregg Stone, MD||Columbia University|