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

This study is not yet open for participant recruitment.
Verified January 2012 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01525888
First received: January 31, 2012
Last updated: February 2, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Radiographic Contrast Agent Nephropathy
 Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period
 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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01525888     History of Changes
Other Study ID Numbers: SOR21711CTIL
Study First Received: January 31, 2012
Last Updated: February 2, 2012
Health Authority: ISRAEL: CLALIT HEALTH SERVISES

Keywords provided by Soroka University Medical Center:
Contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
 Angiotensin Receptor Antagonists
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013