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Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01525888
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Radiographic Contrast Agent Nephropathy Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
No Intervention: control
continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period
Experimental: drug stop
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
Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Soroka University Medical Center Identifier: NCT01525888     History of Changes
Other Study ID Numbers: SOR21711CTIL
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: January 2012
Keywords provided by Soroka University Medical Center:
Contrast induced nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors