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Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

Not Applicable
Completed
Conditions
Coronary Heart Disease
Interventions
Device: Intermittent pneumatic compression of the lower extremities
Registration Number
NCT01064323
Lead Sponsor
Johns Hopkins University
Brief Summary

Intermittent pneumatic compression (IPC) of the lower extremities is a well-established technique for preventing deep vein thrombosis (DVT) and for treating venous stasis. IPC will be done in the home for 3 divided hours every day for 4 weeks. Lab tests, brachial ultrasound and MRI testing will be performed at baseline and after 4 weeks of daily IPC therapy.

See detailed description for increase in healthy control subjects.

Detailed Description

Intermittent pneumatic compression (IPC) of the lower extremities is a well-established technique for preventing deep vein thrombosis (DVT) and for treating venous stasis.

Four categories of discoveries suggest that there may be potential of IPC to have global vascular benefits:

1. IPC of the arms prevents DVT in legs;

2. Nitric oxide released by vascular endothelial cells exerts protective effects on blood vessels;

3. IPC increases nitric oxide availability locally in the lower extremity;

4. Nitric oxide may be transported in blood and released at distant sites, particularly in a hypoxic setting. Therefore, we propose to test the effects of lower extremity IPC on global nitric oxide availability.

We will enroll 4 categories of subjects.

The first 3 categories will have only 1 hour of leg compression. Baseline cholesterol will be drawn for screening labs Brachial ultrasound and NO measurements will be done before and after 1 hr of IPC. No MRI will be done on these groups.

Category 4 will have baseline labs and testing to include:

Brachial ultrasound,NO measurements and MRI will be done before and after 4 weeks of daily IPC therapy.

Category 1, 21-40 yrs healthy male or female

Category 2, 50 yrs plus healthy males or females

Category 3, 50 yrs plus aged matched controls with known heart disease

Category 4, 50 yrs plus12 patients with coronary artery disease.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Intermittent leg compressionIntermittent pneumatic compression of the lower extremitiesIntermittent leg compression daily for 3 hrs a day for 4 weeks
Primary Outcome Measures
NameTimeMethod
Plasma S-nitrosothiolsbaseline

nM

Brachial Diameter1 hour after leg IPC

mm

Brachial Flow Dilation1 hour after IPC

Brachial Flow Mediated dilation, %

Brachial Occlusion-mediated Constriction1 hour after IPC

Brachial Occlusion-mediated constriction measured via ultrasound, %

Plasma Nitrite1 hour after IPC

nM

Brachial Flow Velocity50 minutes into IPC

Measured using ultrasound, units cm/sec.

Red Blood Cell Nitric Oxide1 hour after IPC

nM

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center

🇺🇸

Baltimore, Maryland, United States

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