Peripheral Artery Disease Clinical Trial
Official title:
Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy
The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less
than 0.9 was about 15~30% in patients with end stage renal disease (ESRD), which was higher
than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave
velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis
respectively. In addition, baPWV>2,100 cm/s was shown to be related to potential PAD. ABI
<0.9 was positively associated with vascular access failure in hemodialysis (HD) patients
and our previous study has demonstrated that far infrared (FIR) therapy can improve access
flow and unassisted patency of atrioventricular (AV) fistula.
The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated
with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers
related to endothelial dysfunction in HD patients.
In this study, 300 HD patients will be enrolled to receive ABI and baPWV and about 90
patients (30% according to the literature review) who have abnormal ABI (<0.9) or baPWV
(>2100 cm/sec) will be randomly allocated to FIR group (receiving FIR therapy for 40 minutes
thrice weekly) and control group (without FIR therapy). In patients with abnormal ABI or
baPWV, the effect of single or one-year treatment of FIR on the following items will be
studied: (1) ABI, (2) baPWV and (3) markers related to endothelial dysfunction [including
low and high density lipoprotein cholesterol (LDL and HDL), asymmetric dimethylarginine
(ADMA), hypersensitive C-reactive protein (hsCRP), matrix metalloproteinase-9 (MMP-9)]. The
effect of FIR on PAD or cardiovascular events during one year of follow-up will also be
studied.
This study will allow us to identify the frequency of and the risk factors associated with
abnormal ABI & PWV as well as the effect of single or one-year FIR therapy on ABI & PWV in
HD patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05712395 -
The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
|
N/A | |
| Active, not recruiting |
NCT04534257 -
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
|
N/A | |
| Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
| Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
| Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
| Completed |
NCT02554266 -
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
|
||
| Completed |
NCT03921905 -
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
|
||
| Not yet recruiting |
NCT06369350 -
Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion
|
Early Phase 1 | |
| Recruiting |
NCT04545268 -
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
|
N/A | |
| Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
| Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
| Completed |
NCT02542267 -
In-Stent Restenosis Post-Approval Study
|
N/A | |
| Completed |
NCT02563535 -
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
|
Phase 4 | |
| Completed |
NCT02522884 -
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
|
N/A | |
| Completed |
NCT02228564 -
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
|
N/A | |
| Completed |
NCT02262949 -
A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
|
N/A | |
| Completed |
NCT02145065 -
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
|
N/A | |
| Completed |
NCT01743872 -
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
|
N/A | |
| Recruiting |
NCT01424020 -
Walking Estimated Limitation Calculated by History - Study 2
|
Phase 4 | |
| Active, not recruiting |
NCT01597453 -
NOR-SYS: The Norwegian Stroke in the Young Study
|
N/A |