Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306306
Status:
TERMINATED
Last Update Posted:
2008-08-05
First Post:
2006-03-21
Brief Title:
COOL RCN Cooling to Prevent Radiocontrast Nephropathy
Sponsor:
Radiant Medical
Organization:
Radiant Medical
Study Overview
Official Title:
COOL RCN Cooling to Prevent Radiocontrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None