Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intermittent leg compression Intermittent pneumatic compression of the lower extremities Intermittent leg compression daily for 3 hrs a day for 4 weeks
- Primary Outcome Measures
Name Time Method Plasma S-nitrosothiols baseline nM
Brachial Diameter 1 hour after leg IPC mm
Brachial Flow Dilation 1 hour after IPC Brachial Flow Mediated dilation, %
Brachial Occlusion-mediated Constriction 1 hour after IPC Brachial Occlusion-mediated constriction measured via ultrasound, %
Plasma Nitrite 1 hour after IPC nM
Brachial Flow Velocity 50 minutes into IPC Measured using ultrasound, units cm/sec.
Red Blood Cell Nitric Oxide 1 hour after IPC nM
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States