Radiographic Contrast Agent NephropathyNCT01525888
Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
A study testing stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB) in people with Radiographic Contrast Agent Nephropathy, run by Soroka University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy
- What is being tested?
- stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years,
- chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
- planned coronary angiography
Who cannot join
- 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.
About this study
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.
Read the detailed description
Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
- Keywords
- Contrast induced nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)Procedure or surgery
stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in eGFR from baseline to 48-72 hours following the exposure to the contrast.
Measured: 48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiographic Contrast Agent NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525888
- Sponsor's protocol ID
- SOR21711CTIL
- Status last verified
- Jan 2012
- First submitted
- 31 Jan 2012
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
- ClinicalTrials.gov ID
- NCT01525888
- Acronym / sponsor ID
- SOR21711CTIL
- Conditions
- Radiographic Contrast Agent Nephropathy
- Keywords
- Contrast induced nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period |
| drug stop | Experimental | Procedure: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years,
- chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
- planned coronary angiography
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker | Procedure or surgery | drug stop |
Primary outcome
change in eGFR from baseline to 48-72 hours following the exposure to the contrast.
Time frame: 48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB) in people with Radiographic Contrast Agent Nephropathy, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in eGFR from baseline to 48-72 hours following the exposure to the contrast. (time frame: 48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.