Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Device: Intermittent pneumatic compression of the lower extremities |
Phase 4 |
| Study Type: | Interventional |
| 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 ] [ Designated as safety issue: No ]
- Determine whether intermittent pneumatic compression (IPC) of legs causes arterial vasodilation in the arm. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine whether intermittent pneumatic compression (IPC) of legs increases post-ischemic arterial reactivity in the arm. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Melanie Herr, RN | 410-550-HART | mherr@jhmi.edi |
| 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 |
More Information
No publications provided
| Responsible Party: | Harry SIlber, MD, JHU |
| ClinicalTrials.gov Identifier: | NCT01064323 History of Changes |
| Other Study ID Numbers: | NA00011747 |
| Study First Received: | February 5, 2010 |
| Last Updated: | May 27, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
intermittent pneumatic leg compression nitric oxide vascular endothelial cells |
IPC EECP atherosclerosis |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013