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临床试验/NCT02406131
NCT02406131暂停不适用

Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty: A Pilot Randomized Control Trial

National University of Ireland, Galway, Ireland2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
2
主要终点
Changes in inflammatory and coagulation markers comparing the 2 groups

研究概览

简要总结

The investigators will established relation between restenosis and inflammatory response to shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory response can consequently affect the restenosis rate. There is accumulated evidence that remote ischemic precondition has modifying suppressive effect on inflammatory response and the investigators hypothesized that RIPC may lead to reduction in post angioplasty restenosis rate.

详细描述

Rationale:

The father of interventional radiology Charles Dotter (1920-1985) performed the first percutaneous transluminal angioplasty in university of Oregon hospital on Laura Shaw in 16th of January 1964. She presented with typical rest pain and foot gangrene on left leg and her angiogram show distal superficial femoral artery focal stenosis. He saved her leg and she was walking for the next 3 years of her life using his experimental dilating catheter Later in 1977 Zurich witnessed the first coronary angioplasty by German cardiologist Andreas Gruentzig (1939-1985) using same technique .

The angioplasty utilized gradually in the next years after Dotter to provide less invasive option for the growing number of peripheral vascular disease patients estimated to be in the range of 3% to 10%, increasing to 15% to 20% in persons over 70 years. Early diagnosis remains difficult because patients tends to be asymptomatic up to 50% or more of vessel narrowing. the strong association between prevalence of peripheral vascular disease and age increase the demand with world population ageing specially in western Europe and USA. The lower extremity revascularization USA statistics in year 2000 was 40/100,000 and increasing.

Restenosis or the gradual narrowing of the re vascularized vessel remains one of the main problems usually it occurs within 6 months of angioplasty . Restenosis percentages varies between 12% up to 63 % in different studies largely depends on the lesion type and site with below knee interventions being more liable for restenosis.

The restenosis phenomena can be explained by the physiological response to the trauma caused by the balloon when inflated to compress the atheroma. Many factors can influence the process e.g. patient , procedure and vessel condition before intervention.it can be considered as hypertrophic wound healing from the interaction between monocyte-derived macrophages , T cells and arterial wall .the inflammatory response lead to Neointimal Hyperplasia the terminology uses to describe the proliferation and migration of vascular smooth muscle cells . Elevated inflammatory and coagulation factors markers levels after angioplasty has been suggested as predictors for the possibility of restenosis . The inflammatory theory was more supported when using immunosuppressive drugs like Sirolimus shows positive effects on reducing restenosis rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control Group:

No Intervention

This group will be getting all the routine work up including Duplex scan . we will add request for inflammatory and coagulation markers in their blood samples before and after intervention . The pre-op blood sample will be collected within the 24 hours before intervention and the post intervention in the 24 hrs after (second RIPC window). The repeated duplex scan will be schedule after 6 months.

RIPC Group

Active Comparator

Remote Ischemic Preconditioning Group (RIPC):This group will have all the tests as for the control group with the additional component will be preconditioning. One hour prior to procedure candidates in this group will have structured intermittent periods of induced remote ischaemic preconditioning using standard blood pressure cuffs. The cuff will be inflated to 200 mmHg applied for 5 minutes alternating with 5 minutes rest to the total of 4 cycles, which needs 40 minutes.

干预措施: Remote Ischemic Preconditioning (Other)

结局指标

主要结局

Changes in inflammatory and coagulation markers comparing the 2 groups

时间窗: 24 hours post procedure

CRP FBC D-Dimer Fibrinogen

Restenosis

时间窗: 6 months post procedure

using Duplex scan 30% stenosis increase in time of flow up. Increase of less than or 50 % stenosis to 70% or more. Loss of 50% of gain in luminal diameter.

次要结局

  • Limb Amputation(6 months post procedure)
  • Percentage changes in ABI(6 months post procedure)
  • Progression of Rutherford classification(6 months post procedure)
  • Minor amputations(6 months post procedure)
  • Ulcer formation/ healing(6 months post procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

KHALID AHMED

Mr

National University of Ireland, Galway, Ireland

研究点 (2)

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