NCT01525888

Brief Summary

The aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence the change in estimated glomerular filtration rate or GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 8, 2015

Status Verified

January 1, 2012

Enrollment Period

1.8 years

First QC Date

January 31, 2012

Last Update Submit

June 4, 2015

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

Contrast induced nephropathy

Outcome Measures

Primary Outcomes (1)

  • change in eGFR from baseline to 48-72 hours following the exposure to the contrast.

    48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA

Study Arms (2)

control

NO INTERVENTION

continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period

drug stop

EXPERIMENTAL

temporary stop of angiotensin converting enzyme inhibitor and angiotensin blocker treatment at least 72 hours before coronary angiography and renew of treatment 72 hours after angiography

Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)

Interventions

stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)PROCEDURE

stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker

drug stop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years,
  • chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
  • planned coronary angiography

You may not qualify if:

  • chronic utilization of NSAIDS and Cox-2 selective inhibitors,
  • chronic treatment with mineralocorticosteroid receptor blocker, and
  • administration of contrast within 14 days prior to the enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Angiotensin Receptor Antagonists

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 3, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 8, 2015

Record last verified: 2012-01