Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon
NCT ID: NCT04766749
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
430 participants
INTERVENTIONAL
2021-02-24
2023-05-20
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
The operator did not know if the patient had undergone RIPC. Outcome evaluators also did not know the grouping of patients
Study Groups
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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
RIPC
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
Control
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
No interventions assigned to this group
Interventions
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RIPC
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
Eligibility Criteria
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Inclusion Criteria
* Target vessel diameter\> 2.5mm
Exclusion Criteria
* Diagnose patients with acute myocardial infarction \<24 hours
* Can't tolerate or not suitable for RIPC
* Severe hepatic and renal insufficiency
* Expected survival \<1 year
* Severe calcification needing rotational atherectomy
* Intolerable to dual antiplatelet therapy
18 Years
80 Years
ALL
No
Sponsors
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Henan Institute of Cardiovascular Epidemiology
OTHER
Responsible Party
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Principal Investigators
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Muwei Li, MD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai central China cardiovascular Hospital
Zhengzhou, Henan, China
Countries
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References
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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.
Other Identifiers
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HenanICE202104
Identifier Type: -
Identifier Source: org_study_id