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临床试验/NCT03378024
NCT03378024Unknown不适用

To Evaluate the Correlation of Near Infrared Spectroscopy, ABI, Exercise Test, baPWV and Microalbuminuria With Peripheral Artery Occlusion Disease and Other Atherosclerosis Outcome

Chang Gung Memorial Hospital0 个研究点目标入组 650 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
650
主要终点
Defined APP exercise ABI criteria for PAD diagnosis

研究概览

简要总结

By utilizing Near infrared spectroscopy (NIRS), the local blood flow, tissue oxygenation (StO2), and recovery time of ischemic leg; can be determined. It is reasonable to standardize an easy, simple and safe Active Pedal Plantarflexion (APP) exercise test working load which can achieve the lowest StO2 and other parameters in ischemic leg through observation of NIRS. After standardized of an effective APP test, a determination of a new cutoff value of resting ABI in diagnosing PAD can probably be searched. Analysing the correlation of baPWV with ABI, atherosclerosis risk factors and parameters with atherosclerosis outcome. Observation the Sequential changes of baPWV, ABI and microalbuminuria after managing the atherosclerosis risks, and analyze their influence on the outcome of PAD, coronary artery disease(CAD) and cerebral vascular disease(CVA) outcomes.

详细描述

Exercise testing by Active Pedal Plantar flexion:

The investigators plan to collect 140 cases:

  1. Healthy subjects with no apparent atherosclerotic risk [< 65 y/o, no diabetic mellitus (DM), no hypertension, or no hyperlipidemia, not obese, not current smoker, no smoking history >10 years] 4(n=5)
  2. Patients at risks (e.g. hypertension, hyperlipidemia) (n=5) but without DM,
  3. Type 1 and Type 2 DM patients with normal ABI( >1.0)and normal Toe-brachial index (TBI) (> 0.6) without intermittent claudication(by Edinburgh claudication questionnaire), nor PAD diagnosis (n= 10)
  4. DM normal ABI>1.0 and normal TBI (> 0.6) with suspected symptoms (intermittent claudication, non healing ulcer) (n=10),
  5. DM normal or borderline ABI( >1, 0.91~0.99) but low TBI (< 0.6), or with suspected symptoms (intermittent claudication, non healing ulcer) (n=20),
  6. DM patients with borderline ABI (0.91-0.99) (n=50) with or without leg symptoms,
  7. DM patients abnormal Low ABI (<0.9) (n=30) with or without leg symptoms,
  8. DM patients abnormal high ABI (> 1.3) (n=10)with or without leg symptoms, Post-exercise ABI with APP, and NIRS examination during APP exercise test will be performed.

The investigators also plan to collect 500 cases of nonpregnant, ≥ 40 years old DM patients, obtained baPWV and the resting ABI by oscillometric device (Omron colin, Japan). The investigators will apply this novel technique to assess the extent of arteriosclerosis and atherosclerosis by oscillometric device in our DM patient without PAD (ABI >0.9).

Collect baseline characteristics and follow up annual data: Age, sex, body weight, height, BMI, waist circumferences, history of smoking (ex-smoker, current), coexisting hypertension, hyperlipidemia, DM duration, presence of chronic DM complications of neuropathy, retinopathy (by fundus camera), nephropathy (cr, estimate glomerular filtration rate(eGFR), proteinuria, microalbuminuria). The biochemistry data involving atherosclerotic risk including: systolic blood pressure, diastolic pressure, mean pulse pressure, HbA1c, total cholesterol, LDL-Cholesterol(LDL-C), HDL-Cholesterol(HDL-C), triglyceride, creatinine, microalbuminuria,, high sensitive C-Reactive Protein (hs CRP), baseline EKG all will be collected. All the above data will be followed up annually for 3 years to analyze the correlation of progressive change of baPWV, ABI and microalbuminuria with the atherosclerosis event and mortality.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • type 1 diabetic patients
  • type 2 diabetic patients

排除标准

  • Pregnancy
  • Critical limb ischemia (gangrene change)
  • A permanent pacemaker implant
  • Systolic BP ≥ 200 mmHg or diastolic BP ≥100 mmHg
  • Symptomatic orthostatic blood pressure drop ≥ 20 mmHg
  • Severe critical aortic stenosis
  • Acute medical illness, fever, systemic infection
  • Uncontrolled atrial or ventricular dysrhythmias
  • Uncontrolled sinus tachycardia≥ 120/min
  • Peripheral venous insufficiency, thrombosis or thrombophlebitis
  • Those who has factors known to influence the PWV
  • The brachial-ankle PWV could not be measured on the right and left sides
  • Orthopedic condition (ankle or foot) that cannot perform an active pedal plantar flexion (APP) technique (arthritis, hemiparesis, balance impairment etc.)

结局指标

主要结局

Defined APP exercise ABI criteria for PAD diagnosis

时间窗: 12 month

Design APP exercise with effective working load to defined ABI criteria for PAD diagnosis

Define the correlation between NIRS and ABI

时间窗: 12 month

Analyse the correlation of NIRS with different ABI

The correlation of changes of baPWV and the outcome of PAD

时间窗: 12,24 and 36 months

Analyse the sequential changes of baPWV and the outcome of PAD

The correlation of changes of albuminuria and the outcome of PAD

时间窗: 12,24 and 36 months

Analyse the sequential changes of albuminuria and the outcome of PAD

The correlation of changes of exercise ABI and the outcome of PAD

时间窗: 12,24 and 36 months

Analyse the sequential changes of exercise ABI and the outcome of PAD

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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