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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use
Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been investigated in clinical use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Other | In the control group, all patients were enrolled in a lifestyle intervention |
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| GSPE group | Active Comparator | GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSPE | Drug | GSPE 240 mg/day (120mg bid) |
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| Measure | Description | Time Frame |
|---|---|---|
| Carotid B-Mode Ultrasound | The common, internal, and external carotid arteries were carefully identified by combining B-mode ultrasonography and color-Doppler duplex examination in the anterior oblique, lateral, and posterior oblique planes. All data was collected in 12 segments: the near （intimal-luminal surface) and far (medial- adventitial) walls of the distal common (1 cm proximal to dilation of the carotid bulb), the bifurcation (1cm proximal to the flow divider), and the proximal internal (1 cm section of the internal carotid artery immediately distal to the flow divider) left and right carotid artery. | Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical vascular events | including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death. | after 24 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Qiu, doctor | Qilu Hospital of Shandong University | Study Director |
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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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| lifestyle intervention | Other | dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity |
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