N/A N=10 Diagnostic

Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

Coronary Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT01064323 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Brachial Flow Velocity — 21.0 cm/sec

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intermittent pneumatic compression of the lower extremities (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Brachial Flow Velocity	17.5	—
PRIMARY Brachial Flow Velocity	17.5	—
PRIMARY Brachial Flow Velocity	17.5	—
PRIMARY Brachial Diameter	3.67	—
PRIMARY Brachial Diameter	3.67	—
PRIMARY Brachial Flow Dilation	11.5	0.2
PRIMARY Brachial Flow Dilation	11.5	0.2
PRIMARY Brachial Flow Dilation	11.5	0.2
PRIMARY Brachial Flow Dilation	11.5	0.2
PRIMARY Brachial Occlusion-mediated Constriction	-33	—
PRIMARY Brachial Occlusion-mediated Constriction	-33	—
PRIMARY Brachial Occlusion-mediated Constriction	-33	—
PRIMARY Brachial Occlusion-mediated Constriction	-33	—
PRIMARY Plasma Nitrite	90	—
PRIMARY Plasma Nitrite	90	—
PRIMARY Red Blood Cell Nitric Oxide	6.27	—
PRIMARY Red Blood Cell Nitric Oxide	6.27	—
PRIMARY Plasma S-nitrosothiols	5.79	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01064323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.