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

Not Applicable

Completed

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

• Registration Number: NCT01525888
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-01-31
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug stop	stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)	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

Primary Outcome Measures

Name	Time	Method
change in eGFR from baseline to 48-72 hours following the exposure to the contrast.	48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA