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Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use (GSPE)

Primary Purpose

Atherosclerosis of Arteries of the Extremities, Unspecified

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GSPE
lifestyle intervention
Sponsored by
Jie Qiu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis of Arteries of the Extremities, Unspecified focused on measuring proanthocyanidin,atherosclerosis, carotid plaque

Eligibility Criteria

43 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    control group

    GSPE group

    Arm Description

    In the control group, all patients were enrolled in a lifestyle intervention

    GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    August 14, 2012
    Last Updated
    October 14, 2012
    Sponsor
    Jie Qiu
    Collaborators
    National Natural Science Foundation of China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01707615
    Brief Title
    Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use
    Acronym
    GSPE
    Official Title
    Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jie Qiu
    Collaborators
    National Natural Science Foundation of China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis of Arteries of the Extremities, Unspecified
    Keywords
    proanthocyanidin,atherosclerosis, carotid plaque

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    287 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    In the control group, all patients were enrolled in a lifestyle intervention
    Arm Title
    GSPE group
    Arm Type
    Active Comparator
    Arm Description
    GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
    Intervention Type
    Drug
    Intervention Name(s)
    GSPE
    Other Intervention Name(s)
    Grape seed proanthocyanidin extrat
    Intervention Description
    GSPE 240 mg/day (120mg bid)
    Intervention Type
    Other
    Intervention Name(s)
    lifestyle intervention
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Carotid B-Mode Ultrasound
    Description
    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.
    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.
    Secondary Outcome Measure Information:
    Title
    clinical vascular events
    Description
    including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.
    Time Frame
    after 24 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    43 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jie Qiu, doctor
    Organizational Affiliation
    Qilu Hospital of Shandong University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use

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