Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: transradial coronary intervention |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty |
- Difference of IMT between two groups [ Time Frame: 1 month, 6 months ] [ Designated as safety issue: No ]
- Difference of epicardial fat thickness Difference of cholesterol level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jae-Hyeong Park, MD, PhD | 82-42-280-7167 | jaehpark@cnuh.co.kr |
| Contact: Si Wan Choi, MD, PhD | 82-42-280-8237 | csw1967@cnuh.co.kr |
| Korea, Republic of | |
| Chungnam National University Hospital | Recruiting |
| Daejeon, Korea, Republic of | |
| Contact: Jae-Hyeong Park, MD, PhD 82-42-280-7167 jaehpark@cnuh.co.kr | |
| Principal Investigator: | Jae-Hyeong Park, MD, PhD | Chungnam National University, Chungnam National University Hospital |
More Information
No publications provided
| Responsible Party: | Jae-Hyeong Park, MD, PhD, Chungnam National University, Chungnam National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00952770 History of Changes |
| Other Study ID Numbers: | CNUH-09-07-60 |
| Study First Received: | August 4, 2009 |
| Last Updated: | August 4, 2009 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Chungnam National University:
|
Coronary artery disease Coronary intervention intima-media thickness |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013