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

NCT00952770 | Unknown Phase 4

• 1 other identifier: CNUH-09-07-60
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Coronary intervention; intima-media thickness

Outcome Measures

Primary Outcomes (1)

• Difference of IMT between two groups

  1 month, 6 months

Secondary Outcomes (1)

• Difference of epicardial fat thickness Difference of cholesterol level

  6 months

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Group receiving atorvastatin 20mg/day

Procedure: transradial coronary intervention

Simvastatin/Ezetimibe

ACTIVE COMPARATOR

Group receiving simvastatin/ezetimibe 10/10mg

Procedure: transradial coronary intervention

Interventions

transradial coronary intervention PROCEDURE

percutaneous coronary intervention with transradial approach

Atorvastatin; Simvastatin/Ezetimibe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coronary intervention via the radial artery

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungnam National University: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jae-Hyeong Park, MD, PhD

  Chungnam National University, Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Hyeong Park, MD, PhD

CONTACT

82-42-280-7167; jaehpark@cnuh.co.kr

Si Wan Choi, MD, PhD

CONTACT

82-42-280-8237; csw1967@cnuh.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

KR (1)