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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01071642
First Posted: February 19, 2010
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Talya Wolak, Soroka University Medical Center
  Purpose
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.

Condition Intervention
Blood Pressure 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by Talya Wolak, Soroka University Medical Center:

Primary Outcome Measures:
  • Change in eGFR from baseline to 48 hours following the exposure to the contrast. [ Time Frame: 48 hours after exposure to the contrast ]

Secondary Outcome Measures:
  • 1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization, [ Time Frame: 48-72 hours after exposure to contrast ]

Enrollment: 100
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071642


Locations
Israel
Talya Wolak
Bear Sheva, Israel, 8410
Sponsors and Collaborators
Soroka University Medical Center
  More Information

Responsible Party: Talya Wolak, senior doctor internal medicine department, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01071642     History of Changes
Other Study ID Numbers: sor495209ctil
First Submitted: February 18, 2010
First Posted: February 19, 2010
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Talya Wolak, Soroka University Medical Center:
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

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action