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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:
Information provided by (Responsible Party):
Talya Wolak, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01071642
First received: February 18, 2010
Last updated: October 30, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071642

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

No publications provided

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
Study First Received: February 18, 2010
Last Updated: October 30, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by 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
Enzyme Inhibitors
Angiotensin Receptor Antagonists
 Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013