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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bear Sheva, Israel, 8410
    • Talya Wolak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: continue ace-i and arb's versus dicontinue
Active Comparator: group b	Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure; ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure
Active Comparator: group c	Drug: ACE/ARB stopped 24 hours before procedure and start immediately after; ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Change in eGFR from baseline to 72 hours following the exposure to the contrast.; Rate of eGFR decrease>25% from the baseline; Length of hospitalization.; Requirement of unplanned therapy for elevated blood pressure
• Other Study ID Numbers: sor495209ctil