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Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent pneumatic compression of the lower extremities
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring intermittent pneumatic leg compression, nitric oxide, vascular endothelial cells, IPC, EECP, atherosclerosis

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intermittent leg compression

Arm Description

Intermittent leg compression daily for 3 hrs a day for 4 weeks

Outcomes

Primary Outcome Measures

Brachial Flow Velocity
Brachial flow velocity measured using ultrasound. Units cm/sec.
Brachial Flow Velocity
Measured using ultrasound, units cm/sec.
Brachial Flow Velocity
Measured using ultrasound, units cm/sec.
Brachial Diameter
mm
Brachial Diameter
mm
Brachial Flow Dilation
Brachial Flow Mediated dilation, mm
Brachial Flow Dilation
Brachial Flow Mediated dilation, mm
Brachial Flow Dilation
Brachial Flow Mediated dilation, %
Brachial Flow Dilation
Brachial Flow Mediated dilation, %
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, %
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, %
Plasma Nitrite
nM
Plasma Nitrite
nM
Red Blood Cell Nitric Oxide
nM
Red Blood Cell Nitric Oxide
nM
Plasma S-nitrosothiols
nM

Secondary Outcome Measures

Full Information

First Posted
February 5, 2010
Last Updated
July 18, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01064323
Brief Title
Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
Official Title
Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
intermittent pneumatic leg compression, nitric oxide, vascular endothelial cells, IPC, EECP, atherosclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent leg compression
Arm Type
Other
Arm Description
Intermittent leg compression daily for 3 hrs a day for 4 weeks
Intervention Type
Device
Intervention Name(s)
Intermittent pneumatic compression of the lower extremities
Intervention Description
IPC will be done for 3 divided hours daily for 4 weeks
Primary Outcome Measure Information:
Title
Brachial Flow Velocity
Description
Brachial flow velocity measured using ultrasound. Units cm/sec.
Time Frame
Baseline
Title
Brachial Flow Velocity
Description
Measured using ultrasound, units cm/sec.
Time Frame
5 minutes into leg intermittent pneumatic compression
Title
Brachial Flow Velocity
Description
Measured using ultrasound, units cm/sec.
Time Frame
50 minutes into IPC
Title
Brachial Diameter
Description
mm
Time Frame
baseline
Title
Brachial Diameter
Description
mm
Time Frame
1 hour after leg IPC
Title
Brachial Flow Dilation
Description
Brachial Flow Mediated dilation, mm
Time Frame
baseline
Title
Brachial Flow Dilation
Description
Brachial Flow Mediated dilation, mm
Time Frame
1 hour after IPC
Title
Brachial Flow Dilation
Description
Brachial Flow Mediated dilation, %
Time Frame
baseline
Title
Brachial Flow Dilation
Description
Brachial Flow Mediated dilation, %
Time Frame
1 hour after IPC
Title
Brachial Occlusion-mediated Constriction
Description
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Time Frame
baseline
Title
Brachial Occlusion-mediated Constriction
Description
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Time Frame
1 hour after IPC
Title
Brachial Occlusion-mediated Constriction
Description
Brachial Occlusion-mediated constriction measured via ultrasound, %
Time Frame
baseline
Title
Brachial Occlusion-mediated Constriction
Description
Brachial Occlusion-mediated constriction measured via ultrasound, %
Time Frame
1 hour after IPC
Title
Plasma Nitrite
Description
nM
Time Frame
baseline
Title
Plasma Nitrite
Description
nM
Time Frame
1 hour after IPC
Title
Red Blood Cell Nitric Oxide
Description
nM
Time Frame
baseline
Title
Red Blood Cell Nitric Oxide
Description
nM
Time Frame
1 hour after IPC
Title
Plasma S-nitrosothiols
Description
nM
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Silber, MD
Organizational Affiliation
JHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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