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| ID | Type | Description | Link |
|---|---|---|---|
| 150058B-11 | Other Identifier | ANSM | |
| 15/07-969 | Other Identifier | Comité de Protection des Personnes | |
| 2015-A00076-43 | Other Identifier | ANSM |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cystatin C | Changes of serum Cystatin C between day 0 and day 1, and day 0 and day 2. | 2 days |
| Oxydative stress | Changes in markers of oxydative stress (in the first 40 patients included) :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Mahe, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | Britanny | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32729273 | Result | 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. | |
| 26802296 |
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|
| 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). |
|
| 24 hours |
| Renal function | Changes in serum creatinine and Cystatin C between day 0 and measured values after coronarography (day 6 ). | 6 days |
| Pain | A standardized pain scale (ranged from 0 to 10; 0 : no pain; 10 : maximum of pain). | Day 0 |
| Mortality | Assessment of mortality at six months. | 6 months |
| Koch 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. |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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