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A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)

Primary Purpose

PAD

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous transluminal angioplasty
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PAD focused on measuring Lower Extremity Arterial Occlusive Disease, Interventional Therapy

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age between 40-90 years old.
  • Ankle-brachial index(ABI)<0.9.
  • Lower extremity arterial CT shows that the arterial stenosis>50%

Exclusion Criteria:

  • Type 2 diabetes with acute complications.
  • Type 1 diabetes.
  • Cerebrovascular diseases in the last 3 months.
  • Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months.
  • Hemorrhagic disease.
  • Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy.
  • History of dialysis.
  • Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia.
  • Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  • Fertile woman without contraceptives.
  • Allergic to iodine.
  • Unable to understanding and follow the study protocol orientations.

Sites / Locations

  • The third hospital affiliated to the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional Therapy

Non-Interventional Therapy

Arm Description

Percutaneous transluminal angioplasty.

Outcomes

Primary Outcome Measures

Ankle-brachial index
Mortality(%)
Incidence of amputation(%)

Secondary Outcome Measures

Incidence of major adverse cardiac events (MACE)(%)
High-sensitive C reactive protein(mg/L)
Fasting plasma glucose(mmol/L)
Blood pressure(mmHg)
HbA1c(%)
triglyceride(mmol/L)
total cholesterol(mmol/L)
LDL-c(mmol/L)
HDL-c(mmol/L)
The lower limb transcutaneous oxygen pressure(mmHg)

Full Information

First Posted
March 17, 2016
Last Updated
April 21, 2016
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02752100
Brief Title
A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)
Official Title
Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD
Keywords
Lower Extremity Arterial Occlusive Disease, Interventional Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Therapy
Arm Type
Experimental
Arm Description
Percutaneous transluminal angioplasty.
Arm Title
Non-Interventional Therapy
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Percutaneous transluminal angioplasty
Primary Outcome Measure Information:
Title
Ankle-brachial index
Time Frame
Change from baseline at 1 year(End of Trial)
Title
Mortality(%)
Time Frame
1 year(End of Trial)
Title
Incidence of amputation(%)
Time Frame
1 year(End of Trial)
Secondary Outcome Measure Information:
Title
Incidence of major adverse cardiac events (MACE)(%)
Time Frame
1 year(End of Trial)
Title
High-sensitive C reactive protein(mg/L)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
Fasting plasma glucose(mmol/L)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
Blood pressure(mmHg)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
HbA1c(%)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
triglyceride(mmol/L)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
total cholesterol(mmol/L)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
LDL-c(mmol/L)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
HDL-c(mmol/L)
Time Frame
Change from baseline at 1 year(End of Trial)
Title
The lower limb transcutaneous oxygen pressure(mmHg)
Time Frame
Change from baseline at 1 year(End of Trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age between 40-90 years old. Ankle-brachial index(ABI)<0.9. Lower extremity arterial CT shows that the arterial stenosis>50% Exclusion Criteria: Type 2 diabetes with acute complications. Type 1 diabetes. Cerebrovascular diseases in the last 3 months. Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months. Hemorrhagic disease. Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy. History of dialysis. Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. Fertile woman without contraceptives. Allergic to iodine. Unable to understanding and follow the study protocol orientations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhencheng, MD
Phone
86-023-68757882
Email
zhenchengyan@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Zhiming, MD, PhD
Phone
86-23-68767881
Email
zhuzm@yahoo.com
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD, PhD
Phone
86-023-68705094
Email
zhuzm@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)

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