Renal InsufficiencyPREPARENCT02463604
Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
A study testing Coronary Angiography in people with Renal Insufficiency and Contrast Medium-induced Renal Insufficiency, run by University Hospital, Angers at 1 site in France.
Trial summary
This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Insufficiency, Contrast Medium-induced Renal Insufficiency
- What is being tested?
- Coronary Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to 24 Mar 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient headed to coronary angiography
- Glomerular filtration rate :
- ≤ 40ml/min/1,73m² (MDRD equation)
- or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age > 75 years, NYHA ≥ III/IV, diabetes mellitus
- Signed informed consent
Who cannot join
- Preoperative assessment / dilated cardiomyopathy assessment
- Acute ST-segment elevation myocardial infarction
- Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg
- Resuscitation after cardiac arrest
- Intra-aortic balloon pump
- Contraindication for the repeted use of an upper-arm pressure cuff
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- Extra-renal epuration
- No health insurance coverage
- Legal incapacity (patients under tutorship, curatorship or judicial protection)
- Patient enrolled in another interventional trial or being in a washout period
- Incapacity/impossibility to undergo 12-month follow-up
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.
Read the detailed description
Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.
Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.
We will evaluate the effect of remote preconditioning on renal protection.
- Being tested
- Coronary Angiography
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyProcedure or surgery
Coronary angiography is performed following usual site standards
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Preconditioning | Experimental | A blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total.
The procedure has to be completed between 5 and 60 minutes prior coronary angiography. Receives: Procedure: Coronary Angiography |
| Control | Sham comparator | A blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total.
The procedure has to be completed between 5 and 60 minutes prior coronary angiography. Receives: Procedure: Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in serum creatinin level (≥25% or 0,5mg/dL)
Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy
Measured: 48h after coronary angiography
Secondary outcomes (1)
Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function
Measured: 12 months after coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fabrice Prunier, Professor, Principal investigator, UH Angers, Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463604
- Sponsor's protocol ID
- 2014-A01281-46
- Acronym
- PREPARE
- Status last verified
- Jun 2018
- First submitted
- 2 Jun 2015
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT02463604
- Acronym / sponsor ID
- PREPARE / 2014-A01281-46
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 4 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.
This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.
Detailed description
Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.
Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.
We will evaluate the effect of remote preconditioning on renal protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning | Experimental | Procedure: Coronary AngiographyA blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography. |
| Control | Sham comparator | Procedure: Coronary AngiographyA blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total. The procedure has to be completed between 5 and 60 minutes prior coronary angiography. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient headed to coronary angiography
- Glomerular filtration rate :
- Signed informed consent
Key exclusion criteria (12 listed)
- Preoperative assessment / dilated cardiomyopathy assessment
- Acute ST-segment elevation myocardial infarction
- Cardiogenic shock requiring pressor amine or systolic blood pressure <80mmHg
- Resuscitation after cardiac arrest
- Intra-aortic balloon pump
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 |
|---|---|---|
| Coronary AngiographyCoronary angiography is performed following usual site standards | Procedure or surgery | Control, Remote Ischemic Preconditioning |
Primary outcome
Increase in serum creatinin level (≥25% or 0,5mg/dL)
Time frame: 48h after coronary angiography
Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy
1 secondary outcome
Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function
Time frame: 12 months after coronary angiography
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 25 Jun 2018.
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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.
Fabrice Prunier, Professor principal investigator
UH Angers, Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Angiography in people with Renal Insufficiency and Contrast Medium-induced Renal Insufficiency, run by University Hospital, Angers at 1 site in France.
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 5 inclusion and 12 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 25 Jun 2018. 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 France. 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. Some participants in this study may receive a placebo. 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?
Increase in serum creatinin level (≥25% or 0,5mg/dL) (time frame: 48h after coronary angiography). 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 25 Jun 2018.