Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Intermittent pneumatic compression of the lower extremities

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial Flow Velocity	Brachial flow velocity measured using ultrasound. Units cm/sec.	Baseline
Brachial Flow Velocity	Measured using ultrasound, units cm/sec.	5 minutes into leg intermittent pneumatic compression
Brachial Flow Velocity	Measured using ultrasound, units cm/sec.	50 minutes into IPC
Brachial Diameter	mm	baseline
Brachial Diameter	mm	1 hour after leg IPC
Brachial Flow Dilation	Brachial Flow Mediated dilation, mm	baseline
Brachial Flow Dilation	Brachial Flow Mediated dilation, mm	1 hour after IPC
Brachial Flow Dilation	Brachial Flow Mediated dilation, %	baseline
Brachial Flow Dilation	Brachial Flow Mediated dilation, %	1 hour after IPC
Brachial Occlusion-mediated Constriction	Brachial Occlusion-mediated constriction measured via ultrasound, mm	baseline
Brachial Occlusion-mediated Constriction	Brachial Occlusion-mediated constriction measured via ultrasound, mm	1 hour after IPC
Brachial Occlusion-mediated Constriction	Brachial Occlusion-mediated constriction measured via ultrasound, %	baseline
Brachial Occlusion-mediated Constriction	Brachial Occlusion-mediated constriction measured via ultrasound, %	1 hour after IPC
Plasma Nitrite	nM	baseline
Plasma Nitrite	nM	1 hour after IPC
Red Blood Cell Nitric Oxide	nM	baseline
Red Blood Cell Nitric Oxide	nM	1 hour after IPC
Plasma S-nitrosothiols	nM	baseline

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Harry Silber, MD, JHU

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 5, 2010
• First Submitted That Met QC Criteria: February 5, 2010
• First Posted (Estimate): February 8, 2010

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: atherosclerosis; nitric oxide; IPC; intermittent pneumatic leg compression; vascular endothelial cells; EECP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: NA00011747