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Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.
But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.
RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.
Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.
At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.
The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 40 minutes before PCI by the nurse to the patient RIPC operation (RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times), and then do regular PCI operation |
|
| Control | No Intervention | A standard cuff is placed on the patient's thigh by the nurse 40 minutes before PCI but it is not inflated. PCI is performed 40 minutes later |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC | Other | RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times |
| Measure | Description | Time Frame |
|---|---|---|
| TLF | TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss of target vessel（mm） | Late Lumen Loss of target vessel（mm） by Quantitative Coronary Angiography (QCA). | 6 months |
| DCB expansion time | We hypothesis/speculated that the RIPC group had better ischemia tolerance, so the balloon dilation time was longer than the control group. But the total time for all patients is less than 120 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muwei Li, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai central China cardiovascular Hospital | Zhengzhou | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076569 | Derived | Zhao Z, Yu H, Nie M, Li X, Li M. Remote Ischemic Preconditioning Before Drug-Coated Balloon Implantation can Improve the Long-Term Prognosis of Patients with CAD. Rev Cardiovasc Med. 2024 Mar 27;25(4):116. doi: 10.31083/j.rcm2504116. eCollection 2024 Apr. |
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After the results are published, researchers can obtain IPD from the responsible person on reasonable request
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Before the operation, the nurse chooses the patient to perform RIPC or not according to a predefined random method, and then the operation is performed by the operator.
The operator did not know if the patient had undergone RIPC. Outcome evaluators also did not know the grouping of patients
| less than 120 seconds (On the 1 day of PCI) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |