AtherosclerosisSESANCT01106495
Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis
A study testing Enhanced External Counterpulsation (EECP) and Simvastatin in people with Atherosclerosis, run by Sun Yat-sen University at 1 site in China.
Trial summary
Shear stress maybe the most crucial local factor affecting atherogenesis. The present study investigated the effect of exposure to increased shear stress promoted by Enhanced External Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying inflammation- related molecular mechanisms Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Enhanced External Counterpulsation (EECP) and Simvastatin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20- 70 years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age.
Who cannot join
- Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat- sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Study of the Effect of EECP on Subclinical Atherosclerosis
Shear stress maybe the most crucial local factor affecting atherogenesis. The present study investigated the effect of exposure to increased shear stress promoted by Enhanced External Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying inflammation- related molecular mechanisms
Read the detailed description
Hypercholesterolemic subjects with subclinical atherosclerosis will be randomized into two groups: standard treatment group and standard treatment plus EECP intervention group. The results of ultrasound examination and markers of inflammations will be compared.
- Conditions
- Atherosclerosis
- Being tested
- Enhanced External Counterpulsation (EECP), Simvastatin
- Keywords
- Atherosclerosis, Vascular Endothelium, Counterpulsation, External
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced External Counterpulsation (EECP)Device
Also called EECP
EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period
SimvastatinDrug
Also called Statin
Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. Patients with subclinical atherosclerosis whose serum LDL high than 160mg/ml receive EECP 1- hour session every working day over a 7 week period. Simvastatin is used to decrease cholesterol level for 7 weeks. Receives: Device: Enhanced External Counterpulsation (EECP); Drug: Simvastatin |
| Control | Active comparator | Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intima-media thickness of the carotid artery
Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks
Measured: 7 weeks
Secondary outcomes (2)
Change in vascular endothelial function
Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery
Measured: 7 weeks
Change in serum markers of inflammation
Change from baseline in serum markers of inflammation and laboratory parameters
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2018
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhang, Sun Yat-sen University
- Investigators
- Hong Ma, MD, Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106495
- Sponsor's protocol ID
- EECP-1
- Acronym
- SESA
- Status last verified
- Oct 2020
- First submitted
- 19 Apr 2010
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of EECP on Subclinical Atherosclerosis
- ClinicalTrials.gov ID
- NCT01106495
- Acronym / sponsor ID
- SESA / EECP-1
- Conditions
- Atherosclerosis
- Keywords
- Atherosclerosis, Vascular Endothelium, Counterpulsation, External
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shear stress maybe the most crucial local factor affecting atherogenesis. The present study investigated the effect of exposure to increased shear stress promoted by Enhanced External Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying inflammation- related molecular mechanisms
Detailed description
Hypercholesterolemic subjects with subclinical atherosclerosis will be randomized into two groups: standard treatment group and standard treatment plus EECP intervention group. The results of ultrasound examination and markers of inflammations will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Device: Enhanced External Counterpulsation (EECP), Drug: SimvastatinEnhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. Patients with subclinical atherosclerosis whose serum LDL high than 160mg/ml receive EECP 1- hour session every working day over a 7 week period. Simvastatin is used to decrease cholesterol level for 7 weeks. |
| Control | Active comparator | Drug: SimvastatinSubjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20- 70 years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age.
Key exclusion criteria (1 listed)
- Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
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 |
|---|---|---|
| Enhanced External Counterpulsation (EECP)Also: EECPEECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period | Device | Enhanced External Counterpulsation |
| SimvastatinAlso: StatinSimvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment | Drug | Control, Enhanced External Counterpulsation |
Primary outcome
Change in Intima-media thickness of the carotid artery
Time frame: 7 weeks
Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks
2 secondary outcomes
Change in vascular endothelial function
Time frame: 7 weeks
Change in serum markers of inflammation
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Hong Ma, MD study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced External Counterpulsation (EECP) and Simvastatin in people with Atherosclerosis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 2 Nov 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Intima-media thickness of the carotid artery (time frame: 7 weeks). 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 2 Nov 2020.