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Completed

NCT Number: NCT01064323

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.

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Key information

Conditions

Coronary Heart Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent pneumatic compression of the lower extremities

Device

IPC will be done for 3 divided hours daily for 4 weeks

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2014
First posted
Feb 8, 2010
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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