Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 287
- Primary Endpoint
- Carotid B-Mode Ultrasound
Study Overview
Brief Summary
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 43 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of between 0.9 and 1.2mm; (2) lipid profile: LDL≦3.12mmol/L, TC≦5.2mmol/L; (3) no lipid-lowering treatment within the past 6 months.
Exclusion Criteria
- •severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal failure (serum creatinine ≥117mmol/L), prior carotid endarterectomy, and/or patients who did not agree to participate in the present study.
Arms & Interventions
GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
Intervention: lifestyle intervention (Other)
control group
In the control group, all patients were enrolled in a lifestyle intervention
Intervention: lifestyle intervention (Other)
GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
Intervention: GSPE (Drug)
Outcomes
Primary Outcomes
Carotid B-Mode Ultrasound
Time Frame: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.
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.
Secondary Outcomes
- clinical vascular events(after 24 months follow-up)
Investigators
Jie Qiu
Qilu Hospital of Shandong University
Shandong University