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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiographic Contrast Agent Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No