Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

NCT ID: NCT01064323

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-01-31

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:

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intermittent leg compression

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

Group Type: OTHER

Intermittent pneumatic compression of the lower extremities

Intervention Type: DEVICE

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

Interventions

Intermittent pneumatic compression of the lower extremities

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry Silber, MD

Role: PRINCIPAL_INVESTIGATOR

JHU

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA00011747

Identifier Type: -

Identifier Source: org_study_id