Back to resultsPrevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Primary Purpose
Kidney Disease, Chronic, Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Disease, Chronic
Eligibility Criteria
Inclusion Criteria:
Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:
- Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
- Non ST-elevation acute coronary syndrome with a GRACE score>110
Exclusion Criteria:
- Patients on dialysis or those planned for dialysis in the next 3 months.
- Patients with ST-elevation myocardial infarction
- No symptoms or signs of heart failure
- Treatment with IV diuretics during the 48 hours prior to enrolment
- Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
- Patients post coronary artery bypass surgery
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coronary angiography
Arm Description
Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium
Outcomes
Primary Outcome Measures
Changes in glomerular filtration rate following coronary angiography or intervention
Significant changes are defined as a reduction ≥25% in glomerular filtration rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02468401
Brief Title
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Official Title
The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
5. Study Description
Brief Summary
There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Chronic, Ischemic Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronary angiography
Arm Type
Experimental
Arm Description
Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye
Primary Outcome Measure Information:
Title
Changes in glomerular filtration rate following coronary angiography or intervention
Description
Significant changes are defined as a reduction ≥25% in glomerular filtration rate
Time Frame
24 and 48 hours post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:
Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
Non ST-elevation acute coronary syndrome with a GRACE score>110
Exclusion Criteria:
Patients on dialysis or those planned for dialysis in the next 3 months.
Patients with ST-elevation myocardial infarction
No symptoms or signs of heart failure
Treatment with IV diuretics during the 48 hours prior to enrolment
Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
Patients post coronary artery bypass surgery
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
29393219
Citation
Rozenbaum Z, Benchetrit S, Rozenbaum E, Neumark E, Mosseri M, Pereg D. Ultra-Low Contrast Volume for Patients with Advanced Chronic Kidney Disease Undergoing Coronary Procedures. Nephron. 2018;138(4):296-302. doi: 10.1159/000485648. Epub 2018 Jan 24.
Results Reference
derived
Learn more about this trial
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
We'll reach out to this number within 24 hrs