Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon

NCT04766749 | Completed

• 1 other identifier: HenanICE202104
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Late lumen loss of target vessel（mm）

  6 months

• DCB expansion time

  less than 120 seconds (On the 1 day of PCI)

Study Arms (2)

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

Other: RIPC

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

Interventions

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

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diameter stenosis\>=50% by visual estimation intend to undergo drug-coated balloon implantation
• Target vessel diameter\> 2.5mm

You may not qualify if:

• Chronic Total Obstructive lesion
• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Location

Related Publications (1)

• 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.

  PMID: 39076569 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Muwei Li, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 23, 2021
• Study Start: February 24, 2021
• Primary Completion: February 20, 2022
• Study Completion: May 20, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)