Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
Recruitment status was: Recruiting
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.
|Coronary Heart Disease||Device: Intermittent pneumatic compression of the lower extremities||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study|
- Determine whether intermittent pneumatic compression (IPC) of legs increases systemic plasma nitrite and red blood cell nitric oxide (NO). [ Time Frame: 2 years ]
- Determine whether intermittent pneumatic compression (IPC) of legs causes arterial vasodilation in the arm. [ Time Frame: 2 years ]
- Determine whether intermittent pneumatic compression (IPC) of legs increases post-ischemic arterial reactivity in the arm. [ Time Frame: 2 years ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Intermittent leg compression
Intermittent leg compression daily for 3 hrs a day for 4 weeks
Device: Intermittent pneumatic compression of the lower extremities
IPC will be done for 3 divided hours daily for 4 weeks
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:
- IPC of the arms prevents DVT in legs;
- Nitric oxide released by vascular endothelial cells exerts protective effects on blood vessels;
- IPC increases nitric oxide availability locally in the lower extremity;
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064323
|Contact: Melanie Herr, RN||410-550-HARTemail@example.com|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator: Harry Silber, MD|
|Principal Investigator:||Harry Silber, MD||JHU|