Lower Extremity Atherosclerotic Disease
Conditions
Interventions
Project 1 Experimental Group (LEAD patients):Individual Shear Rate Therapy
Project 1 Control Group (LEAD patients):A Randomized Sham-Controlled Study
Project 2 Experimental Group (Healthy volunteers):Individual Shear Rate Therapy (No control group, self-control)
Sponsors
The Eight Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Lower Extremity Atherosclerosis Disease (Below the Knee) (1) Aged 45-75 years; (2) Ultrasonographic examination of below-the-knee vessels showing significant stenosis (moderate or above) in outpatient, inpatient, and community health center subjects from the Eighth Affiliated Hospital of Sun Yat-sen University University; (3) Fontaine classification I and IIa: [I: Asymptomatic; IIa: Mild claudication; IIb: Moderate to severe claudication; III: Ischemic rest pain; IV: Tissue ulcers or gangrene]; (4) The study has been approved by the Medical Ethics Committee of the Eighth Affiliated Hospital of Sun Yat-Sen University, and the patient or their family has provided informed consent and voluntarily signed the consent form. 2. Healthy Volunteers (1) Male, aged 25-30 years; (2) Body mass index (BMI) between 18.5-23.9, non-smokers, non-drinkers; (3) Health check report from the Health Examination Center of the Eighth Affiliated Hospital of Sun Yat-sen University indicating normal physical condition, with normal blood pressure, lipids, blood sugar, etc., and no history of cardiovascular diseases or medication use; (4) Fully understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with Lower Extremity Atherosclerosis Disease (Below the Knee) (1) Patients with lower limb amputation; (2) Walking impairment caused by reasons other than lower extremity vascular stenosis; (3) Severe foot ulcers or critical limb ischemia; (4) Patients with lower extremity stents; (5) Contraindications for EECP (Enhanced External Counterpulsation): Moderate to severe aortic valve insufficiency; Aortic dissection; Significant pulmonary hypertension; Various bleeding disorders or bleeding tendencies, or use of anticoagulants with INR > 2.0; Various heart valve diseases or congenital heart diseases with heart failure; Active venous inflammation or thrombosis; Severe left heart failure; Uncontrolled high blood pressure (>170/110 mmHg); Uncontrolled arrhythmias, including frequent premature beats, although patients with atrial fibrillation may still benefit; Infection at the limb to be treated with counterpulsation; Severe lower extremity arterial occlusive disease; Pregnancy; (6) Patients with arterial thrombosis or unstable plaques; (7) Patients with severe dysfunction of the heart, liver, kidneys, or lungs; (8) Patients with mental or cognitive disorders; (9) Incomplete personal information or those who withdraw from the study midway. 2. Healthy Volunteers (1) Individuals with a history of coronary heart disease, hypertension, or cerebrovascular disease, or diagnosed metabolic diseases such as diabetes or hyperlipidemia; (2) Individuals with a long history of medication use or who have taken any drugs or foods affecting cardiovascular function within 7 days prior to testing; (3) Contraindications for EECP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated dilation in the brachial artery(FMD);6 minute walking test;8-isoprostane (8-iso-PGF2a);asymmetrical dimethylarginine (ADMA);Quality-of-Life Assessment Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| ankle-brachial index (ABI) ;pulse wave velocity(PWV);flow rate(FR);peak systolic velocity (PSV);Diameter of blood vessel;endothelin-1 (ET-1);soluble vascular cell adhesion molecule-1 (sVCAM-1); | — |
Countries
China
Contacts
Public ContactWu Guifu
The Eight Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed