NephropathyIPC-AngioNCT02470247
Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy in High Risk Patients
A study testing Remote Ischemic Preconditioning (RIPC) in people with Nephropathy, run by Rennes University Hospital at 1 site in France.
Trial summary
Diagnostic imaging for vascular investigations and endovascular procedures frequently require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney injury can appear: the contrast-induced nephropathy (NPCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephropathy
- What is being tested?
- Remote Ischemic Preconditioning (RIPC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2015to 31 Oct 2020
- 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 greater than 18 years, no upper age limit ;
- Patient which may hospitalized for a medical check-up before a percutaneous aortic valve implantation (CTA and coronarography);
- Patient at risk for NPCI defined by a Mehran risk classification system ≥11 (Annexe 2) ;
- Willing to provide free and informed written consent
Who cannot join
- Pathology of the upper-limbs limiting the use of the cuff (bilateral amputation, arteriovenous fistula);
- Critical renal disease requiring hemodialysis ;
- Person who is not affiliated to a health care system insurance
- Inability to understand the instructions of the study;
- Absolute contraindication to of iodinated contrast medium injection (anaphylactic shock history to contrast media, especially Xenetix, clearance (MDRD) less than 30mL/min/1.73m2) ;
- Pregnancy
- Simultaneous participation in other protocol;
- Person with legal protection, person deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IPC-Angio Trial : Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy (Post-diagnostic Imaging) in Patients at High Risk of Contrast-induced Nephropathy
Diagnostic imaging for vascular investigations and endovascular procedures frequently require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney injury can appear: the contrast-induced nephropathy (NPCI).
NPCI is associated with an increase of patients' morbidity and mortality. One of the conventional methods proposed to limit this NPCI is an oral administration of N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours after the injection. However, in some patients this method cannot be performed due to a high risk of heart failure although they are generally at high risk of NPCI.
Read more
Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as compared with NAC and hydration only. .
We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter Aortic Valve Implantation (TAVI)) could be promising.
Read the detailed description
Study design :
Prospective, single-center, randomized, controlled, single-blind, with RIPC procedure (Pre-CI) versus "SHAM" ischemic preconditioning (SHAM Pre -CI) (control). This test will follow the CONSORT Statement (http://www.consort-statement.org/).
This is a randomized, controlled, single-blind trial, assessing the incidence of NPCI (after a CTA ) between two group of patients, one receiving RIPC procedure and the other group receiving a "SHAM" RIPC (control group).
RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion.
RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes. The "SHAM" RIPC will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol).
Main objective :
To assess the efficacy of remote ischemic preconditioning (RIPC) in preventing contrast-induced nephropathy (NPCI) after injected CT scanner in patients at high risk of NPCI.
Secondary objectives :
- To assess the effects of RIPC on a second marker of renal failure (Cystatin C ) ;
- To determine the pathophysiological mechanisms involved in the RIPC (role of oxidative stress ; for the first 40 patients) ;
- To assess the effect of RIPC on renal function after a second injection of contrast-medium during coronary angiography performed 2 to 4 days after the injected CTA ;
- To assess the tolerance of RIPC procedure ;
- To assess the impact on mortality at 6 months.
- Conditions
- Nephropathy
- Being tested
- Remote Ischemic Preconditioning (RIPC), SHAM Remote Ischemic Preconditioning (SHAM RIPC)
- Keywords
- Transcatheter Aortic Valve Implantation
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Preconditioning (RIPC)Other
RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion.
RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes.
SHAM Remote Ischemic Preconditioning (SHAM RIPC)Other
The SHAM Remote Ischemic Preconditioning ("SHAM" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol).
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Remote Ischemic Preconditioning (RIPC) is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion.
RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes. Receives: Other: Remote Ischemic Preconditioning (RIPC) |
| SHAM remote ischemic preconditioning | Sham comparator | The SHAM Remote Ischemic Preconditioning ("SHAM" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol). Receives: Other: SHAM Remote Ischemic Preconditioning (SHAM RIPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NPCI
Incidence of NPCI defined as an increase in serum creatinine ≥ 0.5 mg / dL or a relative increase of 25 % above baseline at 48 hours after contrast medium exposure.
Measured: 48 hours
Secondary outcomes (5)
Cystatin C
Changes of serum Cystatin C between day 0 and day 1, and day 0 and day 2.
Measured: 2 days
Oxydative stress
Changes in markers of oxydative stress (in the first 40 patients included) :
- at day 0, after the RIPC procedure or SHAM-RIPC procedure (+ 5 min) before CTA ;
- after CTA (+ 30 min) and 24 hours after CTA (day 1).
Measured: 24 hours
Renal function
Changes in serum creatinine and Cystatin C between day 0 and measured values after coronarography (day 6 ).
Measured: 6 days
Pain
A standardized pain scale (ranged from 0 to 10; 0 : no pain; 10 : maximum of pain).
Measured: Day 0
Mortality
Assessment of mortality at six months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start6 Oct 2015
- Primary completion24 Aug 2017
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Mahe, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470247
- Sponsor's protocol ID
- 35RC14_9899_IPC-Angio Trial
- Other IDs
- 150058B-11, 15/07-969, 2015-A00076-43
- Acronym
- IPC-Angio
- Status last verified
- May 2023
- First submitted
- 5 Jun 2015
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Belabbas D, Koch C, Chaudru S, Lederlin M, Laviolle B, Le Pabic E, Boulmier D, Heautot JF, Mahe G. Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial. Korean J Radiol. 2020 Nov;21(11):1230-1238. doi: 10.3348/kjr.2019.0916. Epub 2020 Jul 27.
PubMed 32729273Koch C, Chaudru S, Lederlin M, Jaquinandi V, Kaladji A, Mahe G. Remote Ischemic Preconditioning and Contrast-Induced Nephropathy: A Systematic Review. Ann Vasc Surg. 2016 Apr;32:176-87. doi: 10.1016/j.avsg.2015.10.017. Epub 2016 Jan 21.
PubMed 26802296
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPC-Angio Trial : Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy (Post-diagnostic Imaging) in Patients at High Risk of Contrast-induced Nephropathy
- ClinicalTrials.gov ID
- NCT02470247
- Acronym / sponsor ID
- IPC-Angio / 35RC14_9899_IPC-Angio Trial
- Conditions
- Nephropathy
- Keywords
- Transcatheter Aortic Valve Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 12 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.
Diagnostic imaging for vascular investigations and endovascular procedures frequently require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney injury can appear: the contrast-induced nephropathy (NPCI).
NPCI is associated with an increase of patients' morbidity and mortality. One of the conventional methods proposed to limit this NPCI is an oral administration of N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours after the injection. However, in some patients this method cannot be performed due to a high risk of heart failure although they are generally at high risk of NPCI.
Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as compared with NAC and hydration only. .
We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter Aortic Valve Implantation (TAVI)) could be promising.
Detailed description
Study design :
Prospective, single-center, randomized, controlled, single-blind, with RIPC procedure (Pre-CI) versus "SHAM" ischemic preconditioning (SHAM Pre -CI) (control). This test will follow the CONSORT Statement (http://www.consort-statement.org/).
This is a randomized, controlled, single-blind trial, assessing the incidence of NPCI (after a CTA ) between two group of patients, one receiving RIPC procedure and the other group receiving a "SHAM" RIPC (control group).
RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion.
RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes. The "SHAM" RIPC will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol).
Main objective :
To assess the efficacy of remote ischemic preconditioning (RIPC) in preventing contrast-induced nephropathy (NPCI) after injected CT scanner in patients at high risk of NPCI.
Secondary objectives :
- To assess the effects of RIPC on a second marker of renal failure (Cystatin C ) ;
- To determine the pathophysiological mechanisms involved in the RIPC (role of oxidative stress ; for the first 40 patients) ;
- To assess the effect of RIPC on renal function after a second injection of contrast-medium during coronary angiography performed 2 to 4 days after the injected CTA ;
- To assess the tolerance of RIPC procedure ;
- To assess the impact on mortality at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Experimental | Other: Remote Ischemic Preconditioning (RIPC)Remote Ischemic Preconditioning (RIPC) is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion. RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes. |
| SHAM remote ischemic preconditioning | Sham comparator | Other: SHAM Remote Ischemic Preconditioning (SHAM RIPC)The SHAM Remote Ischemic Preconditioning ("SHAM" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years, no upper age limit ;
- Patient which may hospitalized for a medical check-up before a percutaneous aortic valve implantation (CTA and coronarography);
- Patient at risk for NPCI defined by a Mehran risk classification system ≥11 (Annexe 2) ;
- Willing to provide free and informed written consent
Key exclusion criteria (8 listed)
- Pathology of the upper-limbs limiting the use of the cuff (bilateral amputation, arteriovenous fistula);
- Critical renal disease requiring hemodialysis ;
- Person who is not affiliated to a health care system insurance
- Inability to understand the instructions of the study;
- Absolute contraindication to of iodinated contrast medium injection (anaphylactic shock history to contrast media, especially Xenetix, clearance (MDRD) less than 30mL/min/1.73m2) ;
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 |
|---|---|---|
| Remote Ischemic Preconditioning (RIPC)RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion. RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes. | Other | Remote ischemic preconditioning |
| SHAM Remote Ischemic Preconditioning (SHAM RIPC)The SHAM Remote Ischemic Preconditioning ("SHAM" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol). | Other | SHAM remote ischemic preconditioning |
Primary outcome
Incidence of NPCI
Time frame: 48 hours
Incidence of NPCI defined as an increase in serum creatinine ≥ 0.5 mg / dL or a relative increase of 25 % above baseline at 48 hours after contrast medium exposure.
5 secondary outcomes
Cystatin C
Time frame: 2 days
Oxydative stress
Time frame: 24 hours
Renal function
Time frame: 6 days
Pain
Time frame: Day 0
Mortality
Time frame: 6 months
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 24 May 2023.
- Results publication: PubMed 32729273Belabbas D, Koch C, Chaudru S, Lederlin M, Laviolle B, Le Pabic E, Boulmier D, Heautot JF, Mahe G. Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial. Korean J Radiol. 2020 Nov;21(11):1230-1238. doi: 10.3348/kjr.2019.0916. Epub 2020 Jul 27.
- Results publication: PubMed 26802296Koch C, Chaudru S, Lederlin M, Jaquinandi V, Kaladji A, Mahe G. Remote Ischemic Preconditioning and Contrast-Induced Nephropathy: A Systematic Review. Ann Vasc Surg. 2016 Apr;32:176-87. doi: 10.1016/j.avsg.2015.10.017. Epub 2016 Jan 21.
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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.
Guillaume Mahe, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning (RIPC) in people with Nephropathy, run by Rennes University Hospital 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 4 inclusion and 8 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 24 May 2023. 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?
Incidence of NPCI (time frame: 48 hours). 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 NCT02470247, which also lists 2 linked publications.
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 24 May 2023.