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

Soroka University Medical Center

Status: Completed

Conditions: Radiographic Contrast Agent Nephropathy

Treatments: Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)

Study type: Interventional

Funder types: Other

Identifiers

NCT01525888

SOR21711CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

control

No Intervention group

Description:

continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period

drug stop

Experimental group

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

Treatment:

Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)