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

Study Overview
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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.

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

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period | |
| Experimental: drug stop<br>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)<br>* stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in eGFR from baseline to 48-72 hours following the exposure to the contrast. |  | 48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast induced nephropathy