Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent leg compression | Other | Intermittent leg compression daily for 3 hrs a day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent pneumatic compression of the lower extremities | Device | IPC will be done for 3 divided hours daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, % |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harry Silber, MD | JHU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intermittent Leg Compression | Intermittent leg compression for one hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brachial Flow Velocity | Brachial flow velocity measured using ultrasound. Units cm/sec. | Posted | Mean | Standard Deviation | cm/sec | Baseline |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intermittent Leg Compression | Intermittent leg compression for one hour. | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harry Silber, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology | Johns Hopkins University School of Medicine | 410-550-5717 | hsilber@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Brachial Flow Velocity | Measured using ultrasound, units cm/sec. | Posted | Mean | Standard Deviation | cm/sec | 5 minutes into leg intermittent pneumatic compression |
|
|
|
|
| Primary | Brachial Flow Velocity | Measured using ultrasound, units cm/sec. | Posted | Mean | Standard Deviation | cm/sec | 50 minutes into IPC |
|
|
|
| Primary | Brachial Diameter | mm | Posted | Mean | Standard Deviation | mm | baseline |
|
|
|
| Primary | Brachial Diameter | mm | Posted | Mean | Standard Deviation | mm | 1 hour after leg IPC |
|
|
|
| Primary | Brachial Flow Dilation | Brachial Flow Mediated dilation, mm | Posted | Mean | Standard Deviation | mm | baseline |
|
|
|
| Primary | Brachial Flow Dilation | Brachial Flow Mediated dilation, mm | Posted | Mean | Standard Deviation | mm | 1 hour after IPC |
|
|
|
| Primary | Brachial Flow Dilation | Brachial Flow Mediated dilation, % | Posted | Mean | Standard Deviation | percentage of dilation | baseline |
|
|
|
| Primary | Brachial Flow Dilation | Brachial Flow Mediated dilation, % | Posted | Mean | Standard Deviation | percentage of dilation | 1 hour after IPC |
|
|
|
|
| Primary | Brachial Occlusion-mediated Constriction | Brachial Occlusion-mediated constriction measured via ultrasound, mm | Posted | Mean | Standard Deviation | mm | baseline |
|
|
|
| Primary | Brachial Occlusion-mediated Constriction | Brachial Occlusion-mediated constriction measured via ultrasound, mm | Posted | Mean | Standard Deviation | mm | 1 hour after IPC |
|
|
|
| Primary | Brachial Occlusion-mediated Constriction | Brachial Occlusion-mediated constriction measured via ultrasound, % | Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality. | Posted | Mean | Standard Deviation | percentage of constriction | baseline |
|
|
|
| Primary | Brachial Occlusion-mediated Constriction | Brachial Occlusion-mediated constriction measured via ultrasound, % | Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality. | Posted | Mean | Standard Deviation | percentage of constriction | 1 hour after IPC |
|
|
|
| Primary | Plasma Nitrite | nM | Posted | Mean | Standard Deviation | nM | baseline |
|
|
|
| Primary | Plasma Nitrite | nM | Posted | Mean | Standard Deviation | nM | 1 hour after IPC |
|
|
|
| Primary | Red Blood Cell Nitric Oxide | nM | Data was not collected for 1 participant for this outcome measure. | Posted | Mean | Standard Deviation | nM | baseline |
|
|
|
| Primary | Red Blood Cell Nitric Oxide | nM | Data was not collected for 1 participant for this outcome measure. | Posted | Mean | Standard Deviation | nM | 1 hour after IPC |
|
|
|
| Primary | Plasma S-nitrosothiols | nM | Posted | Mean | Standard Deviation | nM | baseline |
|
|
|
| Primary | Red Blood Cell Nitric Oxide | nM | Posted | Mean | Standard Deviation | nM | 1 hour after IPC |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |