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Rapid reduction in plaque inflammation by sonodynamic therapy inpatients with symptomatic femoropopliteal peripheral artery disease:A randomized controlled trial
- Source :
- International Journal of Cardiology. 325:132-139
- Publication Year :
- 2021
- Publisher :
- Elsevier BV, 2021.
-
Abstract
- Inflammation is actively involved in the clinical manifestation of peripheral artery disease (PAD). Sonodynamic therapy (SDT), a novel non-invasive, plaque-based, macrophage-targeted anti-inflammatory regimen for atherosclerosis has the potential to improve walking performance by reducing plaque inflammation.This phase-2, randomized, sham-controlled, double-blind clinical trial enrolled 32 participants with symptomatic femoropopliteal PAD. The primary outcome was the 30-day change in the target-to-background ratio (TBR) within the most diseased segment (MDS) of the femoropopliteal artery assessed through positron emission tomography/computed tomography (PET/CT). The secondary outcomes were changes in walking performance, limb perfusion, lesional morphology and quality of life measurements.The mean age was 64.7 years and 63% were male. Thirty-one completed follow-up. SDT significantly decreased the MDS TBR by 0.53 (95% CI, -0.70 to -0.36, P 0.001) compared with control. Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P 0.001) and 9.6% (95% CI, -24.5 to -5.3, P = 0.005), respectively, and increased the walking speed score of the Walking Impairment Questionnaire by 16.1 (95% CI, 2.6 to 29.5, P = 0.021) and the physical functioning score of the 36-item Short-Form Health Survey by 10.0 (95% CI, 5.0 to 20.0, P = 0.003) compared with control. These improvements were maintained in the SDT group up to 6-month.SDT rapidly reduced plaque inflammation and improved walking performance among patients with symptomatic PAD.Clinical Trials NCT03457662.
- Subjects :
- Male
medicine.medical_specialty
Walking
030204 cardiovascular system & hematology
law.invention
Peripheral Arterial Disease
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Positron Emission Tomography Computed Tomography
Internal medicine
Limb perfusion
medicine
Humans
030212 general & internal medicine
Inflammation
Inpatients
medicine.diagnostic_test
business.industry
Sonodynamic therapy
Middle Aged
Clinical trial
Regimen
medicine.anatomical_structure
Positron emission tomography
Quality of Life
Cardiology
Female
Cardiology and Cardiovascular Medicine
business
Artery
Subjects
Details
- ISSN :
- 01675273
- Volume :
- 325
- Database :
- OpenAIRE
- Journal :
- International Journal of Cardiology
- Accession number :
- edsair.doi.dedup.....e5955d043e26e28191ba68b9c825b588