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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Active Comparator | Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced External Counterpulsation (EECP) | Device | EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vascular endothelial function | Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery | 7 weeks |
| Change in serum markers of inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Ma, MD | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat- sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Simvastatin | Drug | Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment |
|
|
Change from baseline in serum markers of inflammation and laboratory parameters
| 7 weeks |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |