Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

NCT ID: NCT01106495

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enhanced External Counterpulsation

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.

Group Type EXPERIMENTAL

Enhanced External Counterpulsation (EECP)

Intervention Type DEVICE

EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period

Simvastatin

Intervention Type DRUG

Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment

Control

Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enhanced External Counterpulsation (EECP)

EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period

Intervention Type DEVICE

Simvastatin

Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EECP Statin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 20- 70 years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age.

Exclusion Criteria

* Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yan Zhang

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hong Ma, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Sun Yat- sen University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EECP-1

Identifier Type: -

Identifier Source: org_study_id