The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography

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 RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

Conditions
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Blood Pressure

Intervention / Treatment
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* Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure
* Drug: ACE/ARB stopped 24 hours before procedure and start immediately after


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age>18 years 2. Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) 3. Subjects planned to undergo non-emergent coronary angiography. 4. Signed informed consent Exclusion Criteria: 1. eGFR<30 ml/min at baseline 2. Chronic utilization of NSAIDS and Cox-2 selective inhibitors 3. Chronic treatment with mineralocorticosteroid receptor blocker 4. Systolic blood pressure<90 mmHg 5. Planned staged (repeated) procedure within 48 hours 6. Administration of contrast within 14 days prior to the enrollment 7. contraindication to stop ACE-I or ARB'S

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: continue ace-i and arb's versus dicontinue<br> | |
| Active Comparator: group b<br> | Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure<br>* ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure<br>|
| Active Comparator: group c<br> | Drug: ACE/ARB stopped 24 hours before procedure and start immediately after<br>* ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure<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 hours following the exposure to the contrast. |  | 48 hours after exposure to the contrast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization, |  | 48-72 hours after exposure to contrast | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Length of hospitalization., Change in eGFR from baseline to 72 hours following the exposure to the contrast., Rate of eGFR decrease>25% from the baseline, Requirement of unplanned therapy for elevated blood pressure