Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty

August 4, 2009 updated by: Chungnam National University

Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty

The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing coronary intervention via the radial artery

Exclusion Criteria:

  • Contraindication to statins
  • Left ventricular ejection fraction less than 30%
  • Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
  • Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
  • History of renal dysfunction or a serum creatinine level >2.0 mg/dL
  • Serious noncardiac comorbid disease with a life expectancy <1 year
  • Inability to follow the protocol

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
Experimental: Atorvastatin
Group receiving atorvastatin 20mg/day
Procedure: transradial coronary intervention
percutaneous coronary intervention with transradial approach
Active Comparator: Simvastatin/Ezetimibe
Group receiving simvastatin/ezetimibe 10/10mg
Procedure: transradial coronary intervention
percutaneous coronary intervention with transradial approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of IMT between two groups
Time Frame: 1 month, 6 months
1 month, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference of epicardial fat thickness Difference of cholesterol level
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungnam National University

Investigators

  • Principal Investigator: Jae-Hyeong Park, MD, PhD, Chungnam National University, Chungnam National University Hospital

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

July 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 4, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 4, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUH-09-07-60

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.

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