Kidney Disease, ChronicNCT02468401
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
A study testing Percutaneous coronary intervention in people with Kidney Disease, Chronic and Ischemic Heart Disease, run by Meir Medical Center at 1 site in Israel.
Trial summary
There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Disease, Chronic, Ischemic Heart Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Aug 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:
- Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
- Non ST-elevation acute coronary syndrome with a GRACE score>110
Who cannot join
- Patients on dialysis or those planned for dialysis in the next 3 months.
- Patients with ST-elevation myocardial infarction
- No symptoms or signs of heart failure
- Treatment with IV diuretics during the 48 hours prior to enrolment
- Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
- Patients post coronary artery bypass surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions
- Conditions
- Kidney Disease, Chronic, Ischemic Heart Disease
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye
| Study group | Role | What they receive |
|---|---|---|
| Coronary angiography | Experimental | Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glomerular filtration rate following coronary angiography or intervention
Significant changes are defined as a reduction ≥25% in glomerular filtration rate
Measured: 24 and 48 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Disease, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pereg David, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468401
- Sponsor's protocol ID
- 0103-15-MMC
- Status last verified
- Nov 2016
- First submitted
- 3 Jun 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
Publications
Rozenbaum Z, Benchetrit S, Rozenbaum E, Neumark E, Mosseri M, Pereg D. Ultra-Low Contrast Volume for Patients with Advanced Chronic Kidney Disease Undergoing Coronary Procedures. Nephron. 2018;138(4):296-302. doi: 10.1159/000485648. Epub 2018 Jan 24.
PubMed 29393219
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
- ClinicalTrials.gov ID
- NCT02468401
- Acronym / sponsor ID
- 0103-15-MMC
- Conditions
- Kidney Disease, Chronic, Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jun 2015 (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.
There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary angiography | Experimental | Procedure: Percutaneous coronary interventionPatients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:
- Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
- Non ST-elevation acute coronary syndrome with a GRACE score>110
Key exclusion criteria (6 listed)
- Patients on dialysis or those planned for dialysis in the next 3 months.
- Patients with ST-elevation myocardial infarction
- No symptoms or signs of heart failure
- Treatment with IV diuretics during the 48 hours prior to enrolment
- Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
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 |
|---|---|---|
| Percutaneous coronary interventionPatients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye | Procedure or surgery | Coronary angiography |
Primary outcome
Changes in glomerular filtration rate following coronary angiography or intervention
Time frame: 24 and 48 hours post procedure
Significant changes are defined as a reduction ≥25% in glomerular filtration rate
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 22 Nov 2016.
- Derived from this study: PubMed 29393219Rozenbaum Z, Benchetrit S, Rozenbaum E, Neumark E, Mosseri M, Pereg D. Ultra-Low Contrast Volume for Patients with Advanced Chronic Kidney Disease Undergoing Coronary Procedures. Nephron. 2018;138(4):296-302. doi: 10.1159/000485648. Epub 2018 Jan 24.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Kidney Disease, Chronic and Ischemic Heart Disease, run by Meir Medical Center at 1 site in Israel.
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 6 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in glomerular filtration rate following coronary angiography or intervention (time frame: 24 and 48 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02468401, which also lists 1 linked publication.
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 22 Nov 2016.