Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

NCT01064323 | Completed Results

• 1 other identifier: NA00011747
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

intermittent pneumatic leg compression; nitric oxide; vascular endothelial cells; IPC; EECP; atherosclerosis

Outcome Measures

Primary Outcomes (18)

• Brachial Flow Velocity

  Brachial flow velocity measured using ultrasound. Units cm/sec.

  Baseline

• Brachial Flow Velocity

  Measured using ultrasound, units cm/sec.

  5 minutes into leg intermittent pneumatic compression

• Brachial Flow Velocity

  Measured using ultrasound, units cm/sec.

  50 minutes into IPC

• Brachial Diameter

  mm

  baseline

• Brachial Diameter

  mm

  1 hour after leg IPC

• Brachial Flow Dilation

  Brachial Flow Mediated dilation, mm

  baseline

• Brachial Flow Dilation

  Brachial Flow Mediated dilation, mm

  1 hour after IPC

• Brachial Flow Dilation

  Brachial Flow Mediated dilation, %

  baseline

• Brachial Flow Dilation

  Brachial Flow Mediated dilation, %

  1 hour after IPC

• Brachial Occlusion-mediated Constriction

  Brachial Occlusion-mediated constriction measured via ultrasound, mm

  baseline

• Brachial Occlusion-mediated Constriction

  Brachial Occlusion-mediated constriction measured via ultrasound, mm

  1 hour after IPC

• Brachial Occlusion-mediated Constriction

  Brachial Occlusion-mediated constriction measured via ultrasound, %

  baseline

• Brachial Occlusion-mediated Constriction

  Brachial Occlusion-mediated constriction measured via ultrasound, %

  1 hour after IPC

• Plasma Nitrite

  nM

  baseline

• Plasma Nitrite

  nM

  1 hour after IPC

• Red Blood Cell Nitric Oxide

  nM

  baseline

• Red Blood Cell Nitric Oxide

  nM

  1 hour after IPC

• Plasma S-nitrosothiols

  nM

  baseline

Study Arms (1)

Intermittent leg compression

OTHER

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

Device: Intermittent pneumatic compression of the lower extremities

Interventions

Intermittent pneumatic compression of the lower extremities DEVICE

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

Intermittent leg compression

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Coronary Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Harry Silber, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology
• Organization: Johns Hopkins University School of Medicine

hsilber@jhmi.edu

410-550-5717

Study Officials

• Harry Silber, MD

  JHU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: January 1, 2014
• Last Updated: August 17, 2017
• Results First Posted: August 17, 2017

Record last verified: 2017-07

Locations

US (1)