Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01064323
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Intermittent pneumatic compression of the lower extremities Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
Actual Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : January 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Brachial Flow Velocity [ Time Frame: Baseline ]
    Brachial flow velocity measured using ultrasound. Units cm/sec.

  2. Brachial Flow Velocity [ Time Frame: 5 minutes into leg intermittent pneumatic compression ]
    Measured using ultrasound, units cm/sec.

  3. Brachial Flow Velocity [ Time Frame: 50 minutes into IPC ]
    Measured using ultrasound, units cm/sec.

  4. Brachial Diameter [ Time Frame: baseline ]
    mm

  5. Brachial Diameter [ Time Frame: 1 hour after leg IPC ]
    mm

  6. Brachial Flow Dilation [ Time Frame: baseline ]
    Brachial Flow Mediated dilation, mm

  7. Brachial Flow Dilation [ Time Frame: 1 hour after IPC ]
    Brachial Flow Mediated dilation, mm

  8. Brachial Flow Dilation [ Time Frame: baseline ]
    Brachial Flow Mediated dilation, %

  9. Brachial Flow Dilation [ Time Frame: 1 hour after IPC ]
    Brachial Flow Mediated dilation, %

  10. Brachial Occlusion-mediated Constriction [ Time Frame: baseline ]
    Brachial Occlusion-mediated constriction measured via ultrasound, mm

  11. Brachial Occlusion-mediated Constriction [ Time Frame: 1 hour after IPC ]
    Brachial Occlusion-mediated constriction measured via ultrasound, mm

  12. Brachial Occlusion-mediated Constriction [ Time Frame: baseline ]
    Brachial Occlusion-mediated constriction measured via ultrasound, %

  13. Brachial Occlusion-mediated Constriction [ Time Frame: 1 hour after IPC ]
    Brachial Occlusion-mediated constriction measured via ultrasound, %

  14. Plasma Nitrite [ Time Frame: baseline ]
    nM

  15. Plasma Nitrite [ Time Frame: 1 hour after IPC ]
    nM

  16. Red Blood Cell Nitric Oxide [ Time Frame: baseline ]
    nM

  17. Red Blood Cell Nitric Oxide [ Time Frame: 1 hour after IPC ]
    nM

  18. Plasma S-nitrosothiols [ Time Frame: baseline ]
    nM


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064323


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Harry Silber, MD JHU
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01064323    
Other Study ID Numbers: NA00011747
First Posted: February 8, 2010    Key Record Dates
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017
Last Verified: July 2017
Keywords provided by Johns Hopkins University:
intermittent pneumatic leg compression
nitric oxide
vascular endothelial cells
 IPC
EECP
atherosclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases