CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
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|ClinicalTrials.gov Identifier: NCT02740699|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2016
Last Update Posted : March 8, 2022
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 individual s arterial plaque has decreased while taking statins.
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.
Men ages 40-75 and women ages 40-75 who are good candidates for statin treatment
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Drug: Rosuvastatin Drug: Atorvastatin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction|
|Actual Study Start Date :||April 11, 2016|
|Actual Primary Completion Date :||January 27, 2022|
|Estimated Study Completion Date :||March 10, 2023|
Moderate to high intensity treatment
Participants will receive 20-40 mg once daily Rosuvatain, or Participants will receive 40-80 mg once daily of Atrovastin.
Participants will receive 20-40 mg once daily
Participants will receive 40-80 mg once daily.
- To prospectively compare the change in coronary artery plaque burden determined by CCTA in asymptomatic individuals with moderate CVD risk treated either a) according to 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Athe... [ Time Frame: 24 months ]compare the change in coronary artery plaque burden determined by CCTA in asymptomatic individuals with moderate CVD risk treated either a) according to 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults versus b) high intensity statin therapy.
- long-term effects of the statin therapy [ Time Frame: 36 months ]1)Change in noncalcified plaque volume assessed by CCTA at the end of 36 months; 2)Effects of covariates including age, sex, race, body mass index and baseline plaque volume on the change of plaque volume measured by CCTA at 24 and 36 months. 3) The relationship of CMR T1 high signal intensity plaque and change in T1 signal by CMR over time to CCTA plaque characteristics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740699
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Nehal N Mehta, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|