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出境医 / 临床实验 / Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication

Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication

Study Description
Brief Summary:
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Combination Product: Sonodynamic therapy(SDT) Phase 1 Phase 2

Detailed Description:

Atherosclerotic lower extremity PAD affects the living quality of more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most evident symptom. Current claudication therapies reveal significant limitations. Pharmacotherapy and exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication. However, they may not achieve an ideal clinical therapeutic effect. Furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.

The aim of this trial is to verify the hypothesis that SDT can reduce the inflammation of PVAT and improve PWT among PAD patients with symptom of intermittent claudication.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Sonodynamic therapy(SDT)
Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.
 Combination Product: Sonodynamic therapy(SDT)
Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%.
Outcome Measures
Primary Outcome Measures :
  1. Change in PVAT Density, as assessed by CTA [ Time Frame: Measured at Baseline, 1, 3 months ]
    The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.


Secondary Outcome Measures :
  1. PWT change, mins [ Time Frame: Measured at Baseline, 1, 3 months ]
    Changes from baseline peak walking time (PWT) at 1 month is assessed by graded treadmill test (Gardner protocol). The patient continues the test until walking can no longer be tolerated because of claudication symptoms.

  2. Change in peak flow velocity, as assessed by doppler ultrasound [ Time Frame: Measured at Baseline, 1, 3 months ]
    The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound.

  3. Incidence of adverse events [ Time Frame: Measured at Baseline, 1, 3 months ]
    Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction

  4. Plasma adipokines level [ Time Frame: Measured at Baseline, 1, 3 months ]
    Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP

  5. Plasma inflammation cytokine level [ Time Frame: Measured at Baseline, 1, 3 months ]
    Including Interleukin-6(IL-6), IL-10, IL-1β, TGF-α, CRP, EGF, glutathione(GSH) and TGSH.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 40-80 years
  • Patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the Gardner protocol)
  • Femoral popliteal artery with 50% stenosis by ultrasound
  • Stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening
  • Written informed consent

Exclusion Criteria:

  • Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
  • Critical limb ischemia or other comorbid conditions that limit walking ability
  • Non-atherosclerotic peripheral artery stenosis
  • Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
  • Systemic disorders such as hepatic, renal, hematologic, and malignant disease
  • Allergic to contrast media with iodine
  • Contraindication to CTA
  • Allergic to DVDMS
  • Diagnosis of porphyria
  • Pregnant women and nursing mothers
  • Patient who is attending other clinical trial
Contacts and Locations

Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
Layout table for investigator information
Principal Investigator: Ye Tian, MD,PHD First Affiliated Hospital of Harbin Medical University
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date April 15, 2021
Estimated Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		Change in PVAT Density, as assessed by CTA [ Time Frame: Measured at Baseline, 1, 3 months ]
The changes in CT attenuation (HU) of perivascular adipose tissue(PVAT) as assessed by CTA.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • PWT change, mins [ Time Frame: Measured at Baseline, 1, 3 months ]
    Changes from baseline peak walking time (PWT) at 1 month is assessed by graded treadmill test (Gardner protocol). The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
  • Change in peak flow velocity, as assessed by doppler ultrasound [ Time Frame: Measured at Baseline, 1, 3 months ]
    The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound.
  • Incidence of adverse events [ Time Frame: Measured at Baseline, 1, 3 months ]
    Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
  • Plasma adipokines level [ Time Frame: Measured at Baseline, 1, 3 months ]
    Including adiponectin, vaspin, apelin, leptin, visfatin, resistin and FABP
  • Plasma inflammation cytokine level [ Time Frame: Measured at Baseline, 1, 3 months ]
    Including Interleukin-6(IL-6), IL-10, IL-1β, TGF-α, CRP, EGF, glutathione(GSH) and TGSH.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
Official Title  ICMJE Sonodynamic Therapy in the Treatment of Perivascular Adipose Tissue on Patients With PAD and Claudication
Brief Summary The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing the inflammation of perivascular adipose tissue and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients with symptom of intermittent claudication.
Detailed Description

Atherosclerotic lower extremity PAD affects the living quality of more than 20 million people in the world. PAD is associated with a major decline in functional status and claudication is the most evident symptom. Current claudication therapies reveal significant limitations. Pharmacotherapy and exercise are recommended in 2016 AHA/ACC Guideline on the management of lower extremity PAD patients with claudication. However, they may not achieve an ideal clinical therapeutic effect. Furthermore, endovascular procedure may not be feasible, durable or cost-effective, especially in femoropopliteal arteries.

The aim of this trial is to verify the hypothesis that SDT can reduce the inflammation of PVAT and improve PWT among PAD patients with symptom of intermittent claudication.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Combination Product: Sonodynamic therapy(SDT)
Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%.
Study Arms  ICMJE Experimental: Sonodynamic therapy(SDT)
Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.
Intervention: Combination Product: Sonodynamic therapy(SDT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 13, 2021) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		10
Estimated Study Completion Date  ICMJE May 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 40-80 years
  • Patients with atherosclerotic peripheral artery disease with symptoms of moderate to severe intermittent claudication (defined as ability to walk at least 2, but not more than 11 minutes on a graded treadmill test using the Gardner protocol)
  • Femoral popliteal artery with 50% stenosis by ultrasound
  • Stable use of low to moderate dose statin and the permitted statin drugs/ doses: atorvastatin 20 mg, simvastatin 40 mg, rosuvastatin 10 mg, pravastatin, 40 mg, fluvastatin 80 mg or lovastatin 40 mg for at least 6 weeks prior to screening
  • Written informed consent

Exclusion Criteria:

  • Severe aorto-iliac arteries stenosis or occlusion documented by noninvasive and invasive anatomic assessments
  • Critical limb ischemia or other comorbid conditions that limit walking ability
  • Non-atherosclerotic peripheral artery stenosis
  • Active systemic inflammatory disease or have an infectious disease within 1 month prior to enrollment
  • Systemic disorders such as hepatic, renal, hematologic, and malignant disease
  • Allergic to contrast media with iodine
  • Contraindication to CTA
  • Allergic to DVDMS
  • Diagnosis of porphyria
  • Pregnant women and nursing mothers
  • Patient who is attending other clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03967730
Other Study ID Numbers  ICMJE Ye Tian PVAT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party First Affiliated Hospital of Harbin Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Harbin Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ye Tian, MD,PHD First Affiliated Hospital of Harbin Medical University
PRS Account First Affiliated Hospital of Harbin Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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