CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction

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.

Timeline

Start

2016-04-11

Primary completion

2022-01-27

Completion

2022-03-11

Outcome

Outcome not reported

Stopped: “Principal Investigator resigned and closed program”

Publications

• Background D'Ascenzo F, Agostoni P, Abbate A, Castagno D, Lipinski MJ, Vetrovec GW, Frati G, Presutti DG, Quadri G, Moretti C, Gaita F, Zoccai GB. Atherosclerotic coronary plaque regression and the risk of adverse cardiovascular events: a meta-regression of randomized clinical trials. Atherosclerosis. 2013 Jan;226(1):178-85. doi: 10.1016/j.atherosclerosis.2012.10.065. Epub 2012 Nov 6.
• Background Ridker PM, Pradhan A, MacFadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012 Aug 11;380(9841):565-71. doi: 10.1016/S0140-6736(12)61190-8.
• Background Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.

Drugs

Indications