Trial Outcomes & Findings for Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study (NCT NCT01064323)

NCT ID: NCT01064323

Last Updated: 2017-08-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-08-17

Participant Flow

Participant milestones

Measure	Intermittent Leg Compression Intermittent leg compression for one hour.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study

Baseline characteristics by cohort

Measure	Intermittent Leg Compression n=10 Participants 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
Age, Customized 24-39 years old	10 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Velocity	21.0 cm/sec Standard Deviation 6.5

PRIMARY outcome

Timeframe: 5 minutes into leg intermittent pneumatic compression

Measured using ultrasound, units cm/sec.

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Velocity	18 cm/sec Standard Deviation 6.2

PRIMARY outcome

Timeframe: 50 minutes into IPC

Measured using ultrasound, units cm/sec.

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Velocity	17.5 cm/sec Standard Deviation 5.8

PRIMARY outcome

Timeframe: baseline

mm

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Diameter	3.69 mm Standard Deviation 0.70

PRIMARY outcome

Timeframe: 1 hour after leg IPC

mm

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Diameter	3.67 mm Standard Deviation 0.68

PRIMARY outcome

Timeframe: baseline

Brachial Flow Mediated dilation, mm

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Dilation	0.45 mm Standard Deviation 0.27

PRIMARY outcome

Timeframe: 1 hour after IPC

Brachial Flow Mediated dilation, mm

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Dilation	3.69 mm Standard Deviation 0.70

PRIMARY outcome

Timeframe: baseline

Brachial Flow Mediated dilation, %

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Dilation	13.3 percentage of dilation Standard Deviation 9.4

PRIMARY outcome

Timeframe: 1 hour after IPC

Brachial Flow Mediated dilation, %

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Flow Dilation	11.5 percentage of dilation Standard Deviation 7.2

PRIMARY outcome

Timeframe: baseline

Brachial Occlusion-mediated constriction measured via ultrasound, mm

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Occlusion-mediated Constriction	-1.54 mm Standard Deviation 0.51

PRIMARY outcome

Timeframe: 1 hour after IPC

Brachial Occlusion-mediated constriction measured via ultrasound, mm

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Brachial Occlusion-mediated Constriction	-1.15 mm Standard Deviation 0.40

PRIMARY outcome

Timeframe: baseline

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

Brachial Occlusion-mediated constriction measured via ultrasound, %

Outcome measures

Measure	Intermittent Leg Compression n=8 Participants Intermittent leg compression for one hour.
Brachial Occlusion-mediated Constriction	-43 percentage of constriction Standard Deviation 13

PRIMARY outcome

Timeframe: 1 hour after IPC

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

Brachial Occlusion-mediated constriction measured via ultrasound, %

Outcome measures

Measure	Intermittent Leg Compression n=8 Participants Intermittent leg compression for one hour.
Brachial Occlusion-mediated Constriction	-33 percentage of constriction Standard Deviation 12

PRIMARY outcome

Timeframe: baseline

nM

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Plasma Nitrite	112 nM Standard Deviation 26

PRIMARY outcome

Timeframe: 1 hour after IPC

nM

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Plasma Nitrite	90 nM Standard Deviation 15

PRIMARY outcome

Timeframe: baseline

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

nM

Outcome measures

Measure	Intermittent Leg Compression n=9 Participants Intermittent leg compression for one hour.
Red Blood Cell Nitric Oxide	129 nM Standard Deviation 72

PRIMARY outcome

Timeframe: 1 hour after IPC

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

nM

Outcome measures

Measure	Intermittent Leg Compression n=9 Participants Intermittent leg compression for one hour.
Red Blood Cell Nitric Oxide	102 nM Standard Deviation 41

PRIMARY outcome

Timeframe: baseline

nM

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Plasma S-nitrosothiols	5.79 nM Standard Deviation 4.81

PRIMARY outcome

Timeframe: 1 hour after IPC

nM

Outcome measures

Measure	Intermittent Leg Compression n=10 Participants Intermittent leg compression for one hour.
Red Blood Cell Nitric Oxide	6.27 nM Standard Deviation 5.79

Adverse Events

Intermittent Leg Compression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harry Silber, M.D., Ph.D. Assistant Professor of Medicine, Division of Cardiology

Johns Hopkins University School of Medicine

Phone: 410-550-5717

Email: hsilber@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place