- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707615
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use (GSPE)
October 14, 2012 updated by: Jie Qiu
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
287
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: control group
In the control group, all patients were enrolled in a lifestyle intervention
|
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
|
Active Comparator: GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
|
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
GSPE 240 mg/day (120mg bid)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical vascular events
Time Frame: after 24 months follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jie Qiu, doctor, Qilu Hospital of Shandong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
August 14, 2012
First Submitted That Met QC Criteria
October 14, 2012
First Posted (Estimate)
October 16, 2012
Study Record Updates
Last Update Posted (Estimate)
October 16, 2012
Last Update Submitted That Met QC Criteria
October 14, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Atherosclerosis
- Plaque, Atherosclerotic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Protective Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antioxidants
- Proanthocyanidin
Other Study ID Numbers
- 2010GGC10294
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atherosclerosis of Arteries of the Extremities, Unspecified
-
Boston Scientific CorporationCompletedAtherosclerosis of Native Arteries of the Extremities, UnspecifiedBelgium, United States, United Kingdom, Japan, Austria, Canada, Germany
-
Boston Scientific CorporationCompletedAtherosclerosis of Native Arteries of the ExtremitiesNew Zealand, United States, Belgium, Canada, Japan, Germany, Austria
-
Boston Scientific CorporationCompletedAtherosclerosis of Native Arteries of the ExtremitiesNew Zealand, Germany, Belgium, Australia, Austria
-
Meshalkin Research Institute of Pathology of CirculationTerminatedСhronic Ischemia of the Lower Extremities | Atherosclerosis of the Tibial Arteries | Lesion no More Than Two Tibial Arteries | Steno-occlusive Lesion of the Tibial ArteriesRussian Federation
-
SoundBite Medical Solutions, Inc.ethica Clinical Research Inc.; Prairie Vascular Research Inc.CompletedChronic Total Occlusion of Arteries of the ExtremitiesUnited States, Canada
-
Versono Medical LtdCompletedChronic Total Occlusion of Arteries of the ExtremitiesDominican Republic
-
Meshalkin Research Institute of Pathology of CirculationCompletedAtherosclerosis of the Peripheral ArteriesRussian Federation
-
Assiut UniversityNot yet recruitingChronic Limb-Threatening Ischemia Nos of Native Arteries of ExtremitiesEgypt
-
University of WashingtonExelixisActive, not recruitingStage I Soft Tissue Sarcoma of the Trunk and Extremities | Stage II Soft Tissue Sarcoma of the Trunk and Extremities | Sarcoma of the Extremity | Stage IA Soft Tissue Sarcoma of the Trunk and Extremities | Stage IB Soft Tissue Sarcoma of the Trunk and ExtremitiesUnited States
-
Lumen BiomedicalCompleted
Clinical Trials on lifestyle intervention
-
Sheba Medical CenterD-Cure, Israel; Chief Scientist, The Israel Ministry of ScienceCompleted
-
Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Michael... and other collaboratorsActive, not recruiting
-
Northwestern UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHyperglycemia | Glucose Metabolism Disorders | Metabolic Diseases | Obesity | Diabetes Mellitus | Endocrine System Diseases | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Signs and SymptomsUnited States
-
Mayo ClinicCompletedObesityUnited States
-
DongGuk UniversityNational Research Foundation of KoreaUnknown
-
Laval UniversityActive, not recruitingPhysical Activity | Weight Loss | Dietary Modification | BreastfeedingCanada
-
University of AdelaideCompletedInsulin Resistance | Type 2 DiabetesAustralia
-
Molde University CollegeNorwegian Labour and Welfare AdministrationCompletedObesity | Morbid Obesity | Work Related Illnesses | Life Style | Sick-leave
-
Umeå UniversityActive, not recruitingHypertension,Essential | Lifestyle-related ConditionSweden
-
Beth Israel Deaconess Medical CenterCenter for Nutritional Research Charitable TrustCompletedObesity | Weight GainUnited States