- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378024
Evaluate the Correlation of NIRS, ABI, Exercise, baPWV and Albuminuria With Peripheral Artery Occlusion Disease (PAD) and Other Atherosclerosis Outcomes
To Evaluate the Correlation of Near Infrared Spectroscopy, ABI, Exercise Test, baPWV and Microalbuminuria With Peripheral Artery Occlusion Disease and Other Atherosclerosis Outcome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Exercise testing by Active Pedal Plantar flexion:
The investigators plan to collect 140 cases:
- Healthy subjects with no apparent atherosclerotic risk [< 65 y/o, no diabetic mellitus (DM), no hypertension, or no hyperlipidemia, not obese, not current smoker, no smoking history >10 years] 4(n=5)
- Patients at risks (e.g. hypertension, hyperlipidemia) (n=5) but without DM,
- Type 1 and Type 2 DM patients with normal ABI( >1.0)and normal Toe-brachial index (TBI) (> 0.6) without intermittent claudication(by Edinburgh claudication questionnaire), nor PAD diagnosis (n= 10)
- DM normal ABI>1.0 and normal TBI (> 0.6) with suspected symptoms (intermittent claudication, non healing ulcer) (n=10),
- DM normal or borderline ABI( >1, 0.91~0.99) but low TBI (< 0.6), or with suspected symptoms (intermittent claudication, non healing ulcer) (n=20),
- DM patients with borderline ABI (0.91-0.99) (n=50) with or without leg symptoms,
- DM patients abnormal Low ABI (<0.9) (n=30) with or without leg symptoms,
- DM patients abnormal high ABI (> 1.3) (n=10)with or without leg symptoms, Post-exercise ABI with APP, and NIRS examination during APP exercise test will be performed.
The investigators also plan to collect 500 cases of nonpregnant, ≥ 40 years old DM patients, obtained baPWV and the resting ABI by oscillometric device (Omron colin, Japan). The investigators will apply this novel technique to assess the extent of arteriosclerosis and atherosclerosis by oscillometric device in our DM patient without PAD (ABI >0.9).
Collect baseline characteristics and follow up annual data: Age, sex, body weight, height, BMI, waist circumferences, history of smoking (ex-smoker, current), coexisting hypertension, hyperlipidemia, DM duration, presence of chronic DM complications of neuropathy, retinopathy (by fundus camera), nephropathy (cr, estimate glomerular filtration rate(eGFR), proteinuria, microalbuminuria). The biochemistry data involving atherosclerotic risk including: systolic blood pressure, diastolic pressure, mean pulse pressure, HbA1c, total cholesterol, LDL-Cholesterol(LDL-C), HDL-Cholesterol(HDL-C), triglyceride, creatinine, microalbuminuria,, high sensitive C-Reactive Protein (hs CRP), baseline EKG all will be collected. All the above data will be followed up annually for 3 years to analyze the correlation of progressive change of baPWV, ABI and microalbuminuria with the atherosclerosis event and mortality.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- type 1 diabetic patients
- type 2 diabetic patients
Exclusion Criteria:
- Pregnancy
- Critical limb ischemia (gangrene change)
- A permanent pacemaker implant
- Systolic BP ≥ 200 mmHg or diastolic BP ≥100 mmHg
- Symptomatic orthostatic blood pressure drop ≥ 20 mmHg
- Severe critical aortic stenosis
- Acute medical illness, fever, systemic infection
- Uncontrolled atrial or ventricular dysrhythmias
- Uncontrolled sinus tachycardia≥ 120/min
- Peripheral venous insufficiency, thrombosis or thrombophlebitis
- Those who has factors known to influence the PWV
- The brachial-ankle PWV could not be measured on the right and left sides
- Orthopedic condition (ankle or foot) that cannot perform an active pedal plantar flexion (APP) technique (arthritis, hemiparesis, balance impairment etc.)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
diabetic mellitus patients
Measure the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) of pre-exercise and post-exercise by the oscillometric (Omron Colin co.). And follow up for 3 years to identify of the correlation with PAD outcome. |
fast measurements of the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) with the oscillometric method (Omron Colin co, Japan)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Define the correlation between NIRS and ABI
Time Frame: 12 month
|
Analyse the correlation of NIRS with different ABI
|
12 month
|
Defined APP exercise ABI criteria for PAD diagnosis
Time Frame: 12 month
|
Design APP exercise with effective working load to defined ABI criteria for PAD diagnosis
|
12 month
|
The correlation of changes of baPWV and the outcome of PAD
Time Frame: 12,24 and 36 months
|
Analyse the sequential changes of baPWV and the outcome of PAD
|
12,24 and 36 months
|
The correlation of changes of exercise ABI and the outcome of PAD
Time Frame: 12,24 and 36 months
|
Analyse the sequential changes of exercise ABI and the outcome of PAD
|
12,24 and 36 months
|
The correlation of changes of albuminuria and the outcome of PAD
Time Frame: 12,24 and 36 months
|
Analyse the sequential changes of albuminuria and the outcome of PAD
|
12,24 and 36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ng Soh Ching, MD, Chang Gung Memorial Hospital, Keelung
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMRPG2F0181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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