Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

Coronary Heart Disease Clinical Trial

Official title:

Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01064323
• Other study ID #: NA00011747
• Status: Recruiting
• Phase: Phase 4
• First received: February 5, 2010
• Last updated: May 27, 2010
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2010
• Source: Johns Hopkins University
• Contact: Melanie Herr, RN
• Phone: 410-550-HART
• Email: mherr[@]jhmi.edi
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Intermittent pneumatic compression of the lower extremities
IPC will be done for 3 divided hours daily for 4 weeks

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether intermittent pneumatic compression (IPC) of legs increases systemic plasma nitrite and red blood cell nitric oxide (NO).		2 years	No
Secondary	Determine whether intermittent pneumatic compression (IPC) of legs causes arterial vasodilation in the arm.		2 years	No
Secondary	Determine whether intermittent pneumatic compression (IPC) of legs increases post-ischemic arterial reactivity in the arm.		2 years	No