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

Blood Pressure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071642
• Other study ID #: sor495209ctil
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: June 20, 2017
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: June 2017
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Talya Wolak	Bear Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in eGFR from baseline to 48 hours following the exposure to the contrast.		48 hours after exposure to the contrast
Secondary	1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization,		48-72 hours after exposure to contrast