CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Active, not recruiting

CT.gov ID

NCT02740699

Collaborator

(none)

108

Enrollment

Location

Arm

82.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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 individual s 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Rosuvastatin Drug: Atorvastatin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction

Actual Study Start Date :

Apr 11, 2016

Actual Primary Completion Date :

Jan 27, 2022

Anticipated Study Completion Date :

Mar 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Drug: Rosuvastatin Participants will receive 20-40 mg once daily Drug: Atorvastatin Participants will receive 40-80 mg once daily.

Arm

Intervention/Treatment

Other: 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.

Drug: Rosuvastatin

Participants will receive 20-40 mg once daily

Drug: Atorvastatin

Participants will receive 40-80 mg once daily.

Outcome Measures

Primary Outcome Measures

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... [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.

Secondary Outcome Measures

long-term effects of the statin therapy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Men greater than or equal to 40 and less than or equal to 75 years of age; women greater than or equal to 40 and less than or equal to 75 years of age
Willing to travel to the NIH for follow-up visits.
Willing to start or modify statin therapy.
Able to understand and sign informed consent.
Eligible for primary prevention statin therapy

Eligible for at least moderate intensity statin according to 2013 ACC/AHA GRCR (i.e., greater than or equal to 5% 10 year cardiovascular risk, https://my.americanheart.org/professional/StatementsGuidelines/Prevention-Guidelines_U CM_457698_SubHomePage.jsp) OR
low (<5%) 10 year cardiovascular risk per 2013 ACC/ AHA and with coronary artery calcium score greater than or equal to 300 Agatston units or greater than or equal to 75 percentile for age, sex, and ethnicity determined per MESA study

(http://www.mesa-nhlbi.org/calcium/input.aspx).

EXCLUSION CRITERIA:

Allergy or prior clinically relevant adverse reaction to Rosuvastatin (does not include minor muscle pain).
High intensity statin treatment for more than 90 days prior to enrollment
LDL greater than or equal to 190 mg/ml
Physician-diagnosed heart attack
Physician-diagnosed stroke or TIA
Physician-diagnosed heart failure
Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
Active treatment for cancer
Prior hypersensitivity reaction to iodinated contrast injection
Known hyperthyroidism.
Acute renal failure, renal transplant, dialysis and renal failure clinically diagnosed.
History of liver transplant or severe liver disease or unexplained elevation of baseline ALT>3x upper limit of normal
Pregnancy and nursing
Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial.
Any other conditions that precludes safety for MRI and/or CT imaging per the researcher s evaluation.
Individuals with hemoglobinopathies or severe asthma.
Severe renal excretory dysfunction, estimated glomerular filtration (eGFR) rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula: eGFR (mL/min/1.73m2) = 175 x (standardized serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) or x 1.212 (if the subject is black)