CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
- Conditions
- Cardiovascular Disease
- Interventions
- Radiation: Cardiac Computed Tomography (CT)Radiation: Cardiac Magnetic Resonance Image (MRI)
- Registration Number
- NCT02740699
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Moderate to High Statin Treatment in Participants with Coronary Artery Plaque Cardiac Computed Tomography (CT) 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. Moderate to High Statin Treatment in Participants with Coronary Artery Plaque Cardiac Magnetic Resonance Image (MRI) 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. Moderate to High Statin Treatment in Participants with Coronary Artery Plaque Atorvastatin 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. Moderate to High Statin Treatment in Participants with Coronary Artery Plaque Rosuvastatin 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.
- Primary Outcome Measures
Name Time Method Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography 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%.
- Secondary Outcome Measures
Name Time Method 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 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%.Linear Mixed-effects Regression Coefficient of Age Effect on Plaque Volume Baseline, 24 months and 36 months Linear mixed-effects regression coefficient of age effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one year increase of age. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
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 sex (female = 0 and male = 1) effect on plaque volume measured by Coronary artery CT angiography (beta coefficient). Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing male verses female (female =0 and male = 1). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
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 Effects race (white = 1 and non-white = 0) effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing race (white = 1 and non-white = 0). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume Baseline, 24 months and 36 months Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one kg/m\^2 increase of BMI. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware.
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States