Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01064323
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Device: Intermittent pneumatic compression of the lower extremities	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Intermittent leg compression Intermittent leg compression daily for 3 hrs a day for 4 weeks	Device: Intermittent pneumatic compression of the lower extremities; IPC will be done for 3 divided hours daily for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Brachial Flow Velocity [Baseline]

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

2. Brachial Flow Velocity [5 minutes into leg intermittent pneumatic compression]

   Measured using ultrasound, units cm/sec.

3. Brachial Flow Velocity [50 minutes into IPC]

   Measured using ultrasound, units cm/sec.

4. Brachial Diameter [baseline]

   mm

5. Brachial Diameter [1 hour after leg IPC]

   mm

6. Brachial Flow Dilation [baseline]

   Brachial Flow Mediated dilation, mm

7. Brachial Flow Dilation [1 hour after IPC]

   Brachial Flow Mediated dilation, mm

8. Brachial Flow Dilation [baseline]

   Brachial Flow Mediated dilation, %

9. Brachial Flow Dilation [1 hour after IPC]

   Brachial Flow Mediated dilation, %

10. Brachial Occlusion-mediated Constriction [baseline]

    Brachial Occlusion-mediated constriction measured via ultrasound, mm

11. Brachial Occlusion-mediated Constriction [1 hour after IPC]

    Brachial Occlusion-mediated constriction measured via ultrasound, mm

12. Brachial Occlusion-mediated Constriction [baseline]

    Brachial Occlusion-mediated constriction measured via ultrasound, %

13. Brachial Occlusion-mediated Constriction [1 hour after IPC]

    Brachial Occlusion-mediated constriction measured via ultrasound, %

14. Plasma Nitrite [baseline]

    nM

15. Plasma Nitrite [1 hour after IPC]

    nM

16. Red Blood Cell Nitric Oxide [baseline]

    nM

17. Red Blood Cell Nitric Oxide [1 hour after IPC]

    nM

18. Plasma S-nitrosothiols [baseline]

    nM

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Harry Silber, MD, JHU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01064323
• Other Study ID Numbers: NA00011747
• First Posted: Feb 8, 2010
• Last Update Posted: Aug 17, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by Johns Hopkins University: intermittent pneumatic leg compression; nitric oxide; vascular endothelial cells; IPC; EECP; atherosclerosis
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Study Results

Participant Flow

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	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
Overall Participants	10
Age, Customized (Count of Participants)
24-39 years old	10 100%
Sex: Female, Male (Count of Participants)
Female	6 60%
Male	4 40%
Region of Enrollment (Count of Participants)
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Brachial Flow Velocity
Description	Brachial flow velocity measured using ultrasound. Units cm/sec.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [cm/sec]	21.0 (6.5)

2. Primary Outcome

Title	Brachial Flow Velocity
Description	Measured using ultrasound, units cm/sec.
Time Frame	5 minutes into leg intermittent pneumatic compression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [cm/sec]	18 (6.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intermittent Leg Compression
	Comments
	Type of Statistical Test	Other
	Comments	Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Paired t-test
	Comments

3. Primary Outcome

Title	Brachial Flow Velocity
Description	Measured using ultrasound, units cm/sec.
Time Frame	50 minutes into IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [cm/sec]	17.5 (5.8)

4. Primary Outcome

Title	Brachial Diameter
Description	mm
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [mm]	3.69 (0.70)

5. Primary Outcome

Title	Brachial Diameter
Description	mm
Time Frame	1 hour after leg IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [mm]	3.67 (0.68)

6. Primary Outcome

Title	Brachial Flow Dilation
Description	Brachial Flow Mediated dilation, mm
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [mm]	0.45 (0.27)

7. Primary Outcome

Title	Brachial Flow Dilation
Description	Brachial Flow Mediated dilation, mm
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [mm]	3.69 (0.70)

8. Primary Outcome

Title	Brachial Flow Dilation
Description	Brachial Flow Mediated dilation, %
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [percentage of dilation]	13.3 (9.4)

9. Primary Outcome

Title	Brachial Flow Dilation
Description	Brachial Flow Mediated dilation, %
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [percentage of dilation]	11.5 (7.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intermittent Leg Compression
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	t-test, 2 sided
	Comments

10. Primary Outcome

Title	Brachial Occlusion-mediated Constriction
Description	Brachial Occlusion-mediated constriction measured via ultrasound, mm
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [mm]	-1.54 (0.51)

11. Primary Outcome

Title	Brachial Occlusion-mediated Constriction
Description	Brachial Occlusion-mediated constriction measured via ultrasound, mm
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [mm]	-1.15 (0.40)

12. Primary Outcome

Title	Brachial Occlusion-mediated Constriction
Description	Brachial Occlusion-mediated constriction measured via ultrasound, %
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	8
Mean (Standard Deviation) [percentage of constriction]	-43 (13)

13. Primary Outcome

Title	Brachial Occlusion-mediated Constriction
Description	Brachial Occlusion-mediated constriction measured via ultrasound, %
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	8
Mean (Standard Deviation) [percentage of constriction]	-33 (12)

14. Primary Outcome

Title	Plasma Nitrite
Description	nM
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [nM]	112 (26)

15. Primary Outcome

Title	Plasma Nitrite
Description	nM
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [nM]	90 (15)

16. Primary Outcome

Title	Red Blood Cell Nitric Oxide
Description	nM
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Data was not collected for 1 participant for this outcome measure.

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	9
Mean (Standard Deviation) [nM]	129 (72)

17. Primary Outcome

Title	Red Blood Cell Nitric Oxide
Description	nM
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

Data was not collected for 1 participant for this outcome measure.

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	9
Mean (Standard Deviation) [nM]	102 (41)

18. Primary Outcome

Title	Plasma S-nitrosothiols
Description	nM
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [nM]	5.79 (4.81)

19. Primary Outcome

Title	Red Blood Cell Nitric Oxide
Description	nM
Time Frame	1 hour after IPC

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
Measure Participants	10
Mean (Standard Deviation) [nM]	6.27 (5.79)

Adverse Events

Arm/Group Title	Intermittent Leg Compression
Arm/Group Description	Intermittent leg compression for one hour.
All Cause Mortality
	Intermittent Leg Compression
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Intermittent Leg Compression
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Intermittent Leg Compression
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.