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The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.
Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication.
Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham remote ischemic preconditioning' | Sham Comparator | In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline |
|
| Remote ischemic preconditioning | Experimental | In the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion. In subjects presenting with BMI > 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Procedure | four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney injury | Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration | 24 and 48 hours after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of periprocedural myocardial infarction | 24 and 48 hours after PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier | Paris | France | ||||
| Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34111564 | Derived | D'Ascenzo F, Femmino S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comita S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7. | |
| 29506674 |
| Label | URL |
|---|---|
| our research website group | View source |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Sham remote ischemic preconditioning | Procedure | In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline. |
|
| Grosseto |
| Italy |
| Azienda Ospedaliere Senese Siena | Siena | Italy |
| Ospedale Maria Vittoria | Turin | 10016 | Italy |
| San Luigi | Turin | 10016 | Italy |
| Città Della Salute e Della Scienza | Turin | Italy |
| Hospital Clínico San Carlos | Madrid | Spain |
| Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefevre T, Gasparetto V, Garbo R, Omede P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |