Coronary Heart Disease
Conditions
Keywords
intermittent pneumatic leg compression, nitric oxide, vascular endothelial cells, IPC, EECP, atherosclerosis
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.
Interventions
DEVICEIntermittent pneumatic compression of the lower extremities
IPC will be done for 3 divided hours daily for 4 weeks
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial Flow Velocity | Baseline | Brachial flow velocity measured using ultrasound. Units cm/sec. |
| Brachial Diameter | baseline | mm |
| Brachial Flow Dilation | baseline | Brachial Flow Mediated dilation, mm |
| Brachial Occlusion-mediated Constriction | baseline | Brachial Occlusion-mediated constriction measured via ultrasound, mm |
| Plasma Nitrite | baseline | nM |
| Red Blood Cell Nitric Oxide | baseline | nM |
| Plasma S-nitrosothiols | baseline | nM |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intermittent Leg Compression Intermittent leg compression daily for 3 hrs a day for 4 weeks
Intermittent pneumatic compression of the lower extremities: IPC will be done for 3 divided hours daily for 4 weeks | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intermittent Leg Compression |
|---|---|
| Age, Customized 24-39 years old | 10 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Brachial Diameter
mm
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Diameter | 3.69 mm | Standard Deviation 0.7 |
Primary
Brachial Diameter
mm
Time frame: 1 hour after leg IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Diameter | 3.67 mm | Standard Deviation 0.68 |
Primary
Brachial Flow Dilation
Brachial Flow Mediated dilation, %
Time frame: 1 hour after IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Dilation | 11.5 percentage of dilation | Standard Deviation 7.2 |
p-value: 0.2t-test, 2 sided
Primary
Brachial Flow Dilation
Brachial Flow Mediated dilation, mm
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Dilation | 0.45 mm | Standard Deviation 0.27 |
Primary
Brachial Flow Dilation
Brachial Flow Mediated dilation, mm
Time frame: 1 hour after IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Dilation | 3.69 mm | Standard Deviation 0.7 |
Primary
Brachial Flow Dilation
Brachial Flow Mediated dilation, %
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Dilation | 13.3 percentage of dilation | Standard Deviation 9.4 |
Primary
Brachial Flow Velocity
Measured using ultrasound, units cm/sec.
Time frame: 50 minutes into IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Velocity | 17.5 cm/sec | Standard Deviation 5.8 |
Primary
Brachial Flow Velocity
Measured using ultrasound, units cm/sec.
Time frame: 5 minutes into leg intermittent pneumatic compression
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Velocity | 18 cm/sec | Standard Deviation 6.2 |
p-value: 0.02Paired t-test
Primary
Brachial Flow Velocity
Brachial flow velocity measured using ultrasound. Units cm/sec.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Flow Velocity | 21.0 cm/sec | Standard Deviation 6.5 |
Primary
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Occlusion-mediated Constriction | -1.54 mm | Standard Deviation 0.51 |
Primary
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Time frame: 1 hour after IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Occlusion-mediated Constriction | -1.15 mm | Standard Deviation 0.4 |
Primary
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, %
Time frame: baseline
Population: Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Occlusion-mediated Constriction | -43 percentage of constriction | Standard Deviation 13 |
Primary
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, %
Time frame: 1 hour after IPC
Population: Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Brachial Occlusion-mediated Constriction | -33 percentage of constriction | Standard Deviation 12 |
Primary
Plasma Nitrite
nM
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Plasma Nitrite | 112 nM | Standard Deviation 26 |
Primary
Plasma Nitrite
nM
Time frame: 1 hour after IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Plasma Nitrite | 90 nM | Standard Deviation 15 |
Primary
Plasma S-nitrosothiols
nM
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Plasma S-nitrosothiols | 5.79 nM | Standard Deviation 4.81 |
Primary
Red Blood Cell Nitric Oxide
nM
Time frame: baseline
Population: Data was not collected for 1 participant for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Red Blood Cell Nitric Oxide | 129 nM | Standard Deviation 72 |
Primary
Red Blood Cell Nitric Oxide
nM
Time frame: 1 hour after IPC
Population: Data was not collected for 1 participant for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Red Blood Cell Nitric Oxide | 102 nM | Standard Deviation 41 |
Primary
Red Blood Cell Nitric Oxide
nM
Time frame: 1 hour after IPC
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Leg Compression | Red Blood Cell Nitric Oxide | 6.27 nM | Standard Deviation 5.79 |