CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography
研究概览
简要总结
Background:
Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease. Drugs called statins might shrink plaque. Researchers want to study how CT scanning can determine if an individuals arterial plaque has decreased while taking statins.
Objectives:
To measure the change in coronary artery plaque volume in people treated with high-intensity statin therapy using CT and MRI scans. To study the metabolic activity of plaque in arteries. To determine how well plaque measurements from heart CT scans can be replicated.
Eligibility:
Men ages 40-75 and women ages 40-75 who are good candidates for statin treatment
Design:
Visit 1: participants will be screened with:
- Medical history
- Blood tests
- Heart MRI and CT scan: An IV inserted into an arm or hand vein removes blood and injects contrast, and medicine if needed. Participants lie on a table that slides into a machine that takes pictures of the body. For the CT scan, if their heart rate is too high, they get medicine to lower it. They breathe in a special way, holding their breath for 5 seconds.
Participants will begin high-intensity statin treatment.
Participants will have 7 more visits over 3 years. All visits include blood tests and medication review. Some may also include:
- Statin treatment adjustment
- CT scan
- MRI scan
- Physical exam
Participants may join the PET Substudy. This includes 5 more visits during the study. These include:
- Getting an IV in an arm vein
- Blood tests
- PET scans: They fast 12 hours before.
Participants may join the Reproducibility Substudy if they had a slow heart rate during their first CT scan. This includes 1 additional heart CT scan 4 weeks later.
详细描述
In high risk patients undergoing invasive angiography, intravascular ultrasound (IVUS) has shown reduction of plaque for patients treated with HMG-CoA reductase inhibitors (statins). However, there is no accepted noninvasive method to determine if treatment for atherosclerosis results in reduction of coronary artery plaque.
Coronary artery CT angiography (CCTA) is noninvasive and can accurately determine the degree of coronary artery stenosis. In addition, the extent of calcified and noncalcified plaque may be directly measured using this technology at low radiation dose using state-of-the-art CT scanners. Several retrospective studies have previously suggested that CCTA may be able to show plaque regression in the coronary arteries due to statin therapy.
The primary aim of this proposal is to determine the change in coronary artery plaque volume in individuals treated with high intensity statin therapy as defined by 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.
Men and women who meet the inclusion and exclusion criteria will undergo CCTA examination for the presence or absence of coronary artery plaque. Individuals with evidence of noncalcified coronary plaque by CCTA and who meet criteria for HMG-CoA reductase (statin) therapy will be evaluated for a total of 36 months. The change of coronary artery plaque (progression or no change, or regression) in individuals with noncalcified plaque at baseline will be measured by CCTA at yearly intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Moderate to High Statin Treatment in Participants with Coronary Artery Plaque
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
干预措施: Rosuvastatin (Drug)
Moderate to High Statin Treatment in Participants with Coronary Artery Plaque
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
干预措施: Atorvastatin (Drug)
Moderate to High Statin Treatment in Participants with Coronary Artery Plaque
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
干预措施: Cardiac Computed Tomography (CT) (Radiation)
Moderate to High Statin Treatment in Participants with Coronary Artery Plaque
Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin.
干预措施: Cardiac Magnetic Resonance Image (MRI) (Radiation)
结局指标
主要结局
Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography
时间窗: Baseline and 24 months
Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C \> or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately \> or = 50%.
次要结局
- Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography(Baseline and 36 months)
- Linear Mixed-effects Regression Coefficient of Age Effect on Plaque Volume(Baseline, 24 months and 36 months)
- Linear Mixed-Effects Regression Coefficient of Sex Effect on Plaque Volume (Beta Coefficient)(Baseline, 24 months and 36 months)
- Linear Mixed-effects Regression Coefficient of Race Effect on Plaque Volume (Beta Coefficient)(Baseline, 24 months and 36 months)
- Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume(Baseline, 24 months and 36 months)