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

NCT01071642 | Completed

• 1 other identifier: sor495209ctil
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Blood Pressure

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

Outcome Measures

Primary Outcomes (1)

• Change in eGFR from baseline to 48 hours following the exposure to the contrast.

  48 hours after exposure to the contrast

Secondary Outcomes (1)

• 1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization,

  48-72 hours after exposure to contrast

Study Arms (3)

continue ace-i and arb's versus dicontinue

NO INTERVENTION

group b

ACTIVE COMPARATOR

Drug: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure

group c

ACTIVE COMPARATOR

Drug: ACE/ARB stopped 24 hours before procedure and start immediately after

Interventions

stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure DRUG

ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure

group b

ACE/ARB stopped 24 hours before procedure and start immediately after DRUG

ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure

group c

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age\>18 years
• \. Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file)
• \. Subjects planned to undergo non-emergent coronary angiography.
• \. Signed informed consent

You may not qualify if:

• \. eGFR\<30 ml/min at baseline
• \. Chronic utilization of NSAIDS and Cox-2 selective inhibitors
• \. Chronic treatment with mineralocorticosteroid receptor blocker
• \. Systolic blood pressure\<90 mmHg
• \. Planned staged (repeated) procedure within 48 hours
• \. Administration of contrast within 14 days prior to the enrollment
• \. contraindication to stop ACE-I or ARB'S

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Talya Wolak

Bear Sheva, 8410, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior doctor internal medicine department

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

IL (1)