Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
Primary Purpose
Radiographic Contrast Agent Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
Sponsored by
About this trial
This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy focused on measuring Contrast induced nephropathy
Eligibility Criteria
Inclusion Criteria:
- age > 18 years,
- chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
- planned coronary angiography
Exclusion Criteria:
- chronic utilization of NSAIDS and Cox-2 selective inhibitors,
- chronic treatment with mineralocorticosteroid receptor blocker, and
- administration of contrast within 14 days prior to the enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
drug stop
Arm Description
continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period
temporary stop of angiotensin converting enzyme inhibitor and angiotensin blocker treatment at least 72 hours before coronary angiography and renew of treatment 72 hours after angiography
Outcomes
Primary Outcome Measures
change in eGFR from baseline to 48-72 hours following the exposure to the contrast.
Secondary Outcome Measures
Full Information
NCT ID
NCT01525888
First Posted
January 31, 2012
Last Updated
June 4, 2015
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01525888
Brief Title
Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence the change in estimated glomerular filtration rate or GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.
Detailed Description
Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiographic Contrast Agent Nephropathy
Keywords
Contrast induced nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period
Arm Title
drug stop
Arm Type
Experimental
Arm Description
temporary stop of angiotensin converting enzyme inhibitor and angiotensin blocker treatment at least 72 hours before coronary angiography and renew of treatment 72 hours after angiography
Intervention Type
Procedure
Intervention Name(s)
stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
Intervention Description
stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Primary Outcome Measure Information:
Title
change in eGFR from baseline to 48-72 hours following the exposure to the contrast.
Time Frame
48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years,
chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
planned coronary angiography
Exclusion Criteria:
chronic utilization of NSAIDS and Cox-2 selective inhibitors,
chronic treatment with mineralocorticosteroid receptor blocker, and
administration of contrast within 14 days prior to the enrollment.
12. IPD Sharing Statement
Learn more about this trial
Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
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