Coronary Heart DiseaseNCT01064323
Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
A study testing Intermittent pneumatic compression of the lower extremities in people with Coronary Heart Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Intermittent pneumatic compression of the lower extremities
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read the 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:
- IPC of the arms prevents DVT in legs;
- Nitric oxide released by vascular endothelial cells exerts protective effects on blood vessels;
- IPC increases nitric oxide availability locally in the lower extremity;
- 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Intermittent pneumatic compression of the lower extremities
- Keywords
- intermittent pneumatic leg compression, nitric oxide, vascular endothelial cells, IPC, EECP, atherosclerosis
- Medical subject headings
- Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent pneumatic compression of the lower extremitiesDevice
IPC will be done for 3 divided hours daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intermittent leg compression | Other | Intermittent leg compression daily for 3 hrs a day for 4 weeks Receives: Device: Intermittent pneumatic compression of the lower extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Flow Velocity
Brachial flow velocity measured using ultrasound. Units cm/sec.
Measured: Baseline
Brachial Flow Velocity
Measured using ultrasound, units cm/sec.
Measured: 5 minutes into leg intermittent pneumatic compression
Brachial Flow Velocity
Measured using ultrasound, units cm/sec.
Measured: 50 minutes into IPC
Brachial Diameter
mm
Measured: baseline
Brachial Diameter
mm
Measured: 1 hour after leg IPC
Brachial Flow Dilation
Brachial Flow Mediated dilation, mm
Measured: baseline
Brachial Flow Dilation
Brachial Flow Mediated dilation, mm
Measured: 1 hour after IPC
Brachial Flow Dilation
Brachial Flow Mediated dilation, %
Measured: baseline
Brachial Flow Dilation
Brachial Flow Mediated dilation, %
Measured: 1 hour after IPC
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Measured: baseline
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Measured: 1 hour after IPC
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, %
Measured: baseline
Brachial Occlusion-mediated Constriction
Brachial Occlusion-mediated constriction measured via ultrasound, %
Measured: 1 hour after IPC
Plasma Nitrite
nM
Measured: baseline
Plasma Nitrite
nM
Measured: 1 hour after IPC
Red Blood Cell Nitric Oxide
nM
Measured: baseline
Red Blood Cell Nitric Oxide
nM
Measured: 1 hour after IPC
Plasma S-nitrosothiols
nM
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Silber, MD, Principal investigator, JHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064323
- Sponsor's protocol ID
- NA00011747
- Status last verified
- Jul 2017
- First submitted
- 5 Feb 2010
- Last updated
- 17 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
- ClinicalTrials.gov ID
- NCT01064323
- Acronym / sponsor ID
- NA00011747
- Conditions
- Coronary Heart Disease
- Keywords
- intermittent pneumatic leg compression, nitric oxide, vascular endothelial cells, IPC, EECP, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- IPC of the arms prevents DVT in legs;
- Nitric oxide released by vascular endothelial cells exerts protective effects on blood vessels;
- IPC increases nitric oxide availability locally in the lower extremity;
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent leg compression | Other | Device: Intermittent pneumatic compression of the lower extremitiesIntermittent leg compression daily for 3 hrs a day for 4 weeks |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent pneumatic compression of the lower extremitiesIPC will be done for 3 divided hours daily for 4 weeks | Device | Intermittent leg compression |
Primary outcome
Brachial Flow Velocity
Time frame: Baseline
Brachial flow velocity measured using ultrasound. Units cm/sec.
Brachial Flow Velocity
Time frame: 5 minutes into leg intermittent pneumatic compression
Measured using ultrasound, units cm/sec.
Brachial Flow Velocity
Time frame: 50 minutes into IPC
Measured using ultrasound, units cm/sec.
Brachial Diameter
Time frame: baseline
mm
Brachial Diameter
Time frame: 1 hour after leg IPC
mm
Brachial Flow Dilation
Time frame: baseline
Brachial Flow Mediated dilation, mm
Brachial Flow Dilation
Time frame: 1 hour after IPC
Brachial Flow Mediated dilation, mm
Brachial Flow Dilation
Time frame: baseline
Brachial Flow Mediated dilation, %
Brachial Flow Dilation
Time frame: 1 hour after IPC
Brachial Flow Mediated dilation, %
Brachial Occlusion-mediated Constriction
Time frame: baseline
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Brachial Occlusion-mediated Constriction
Time frame: 1 hour after IPC
Brachial Occlusion-mediated constriction measured via ultrasound, mm
Brachial Occlusion-mediated Constriction
Time frame: baseline
Brachial Occlusion-mediated constriction measured via ultrasound, %
Brachial Occlusion-mediated Constriction
Time frame: 1 hour after IPC
Brachial Occlusion-mediated constriction measured via ultrasound, %
Plasma Nitrite
Time frame: baseline
nM
Plasma Nitrite
Time frame: 1 hour after IPC
nM
Red Blood Cell Nitric Oxide
Time frame: baseline
nM
Red Blood Cell Nitric Oxide
Time frame: 1 hour after IPC
nM
Plasma S-nitrosothiols
Time frame: baseline
nM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Silber, MD principal investigator
JHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent pneumatic compression of the lower extremities in people with Coronary Heart Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Flow Velocity (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.