Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - 90 |
Updated: | 4/2/2016 |
Start Date: | January 2009 |
End Date: | January 2011 |
Contact: | Melanie Herr, RN |
Email: | mherr@jhmi.edi |
Phone: | 410-550-HART |
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.
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.
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.
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.
Category 1 subjects-healthy volunteers (no MRI required) INCLUSION (N-12) 21 -40 years
male or female EXCLUSIONS History of CAD, MI, Cath,CABG,CTA, positive stress test HTN
uncontrolled (SBP>140 or DBP>90) DM except diet controlled Cholesterol >200 at screening
Smoking last 10 years Acute Medical Illness Inflammatory Phlebitis Infection lower limbs
Recent lower limb surgery
Category 2 subjects ( age matched without CAD)(no MRI required) INCLUSION (N-12) 50 plus
male or female EXCLUSIONS History of CAD, MI, Cath,CABG,CTA, positive stress test HTN
uncontrolled (SBP>140 or DBP>90) DM except diet controlled Cholesterol >200 at screening
Smoking last 10 years Acute Medical Illness Inflammatory Phlebitis Infection lower limbs
Recent lower limb surgery
Category 3 subjects ( age matched with CAD)(no MRI required) INCLUSION (N-up to 5) 50 plus
male or female documented CAD by cath, PTCI, CABG, CTA EXCLUSIONS History of CHF, DVT, PE
Angina, active, needing nitrates Acute Medical Illness Inflammatory Phlebitis Infection
lower limbs Recent lower limb surgery
Category 4 subjects with MRI (original group) INCLUSIONS(N=12) 50 plus male or female
documented CAD by cath, PTCI, CABG, CTA EXCLUSIONS History of CHF, DVT, PE Angina, active,
needing nitrates Atrial Fib BMI>35 (MRI) MRI contraindications pregnancy Chronic
Inflammatory Disease Acute Medical Illness Inflammatory Phlebitis Infection lower limbs
recent lower limb surgery
We found this trial at
1
site
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
Click here to add this to my saved trials