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CT COMPARE: CT COronary Angiography to Measure PlAque REduction

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ClinicalTrials.gov Identifier: NCT02740699
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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 45-75 and women ages 50-75 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CT COMPARE: CT COronary Angiography to Measure PlAque REduction
Study Start Date : April 14, 2016
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Moderate
Moderate intensity treatment
Drug: Atorvastatin
Participants will receive 40-80 mg once daily

High
High intensity treatment
Drug: Rosuvastatin
Participants will receive 20-40 mg once daily

Drug: Atorvastatin
Participants will receive 40-80 mg once daily




Primary Outcome Measures :
  1. 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: one-year, two-years, three-years ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

A. Men greater than or equal to 45 and less than or equal to 75 years of age; women greater than or equal to 50 and less than or equal to 75 years of age

B. Willing to travel to the NIH for follow-up visits.

C. Willing to start or modify statin therapy.

D. Able to understand and sign informed consent.

E. Eligible for primary prevention statin therapy

  1. 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_UCM_457698_SubHomePage.jsp) OR
  2. 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:

A. Allergy or prior clinically relevant adverse reaction to Rosuvastatin (does not include minor muscle pain).

B. High intensity statin treatment for more than 90 days prior to enrollment

C. LDL greater than or equal to 190 mg/ml

D. Physician-diagnosed heart attack

E. Physician-diagnosed angina or taking nitroglycerin

F. Physician-diagnosed stroke or TIA

G. Physician-diagnosed heart failure

H. Current atrial fibrillation

I. Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)

J. Active treatment for cancer

K. Prior hypersensitivity reaction to iodinated contrast injection

L. Known hyperthyroidism.

M. Acute renal failure, renal transplant, dialysis and renal failure clinically diagnosed.

N. History of liver transplant or severe liver disease or unexplained elevation of baseline ALT>3x upper limit of normal

O. Claustrophobia

P. Pregnancy and nursing

Q. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial.

R. Any other conditions that precludes safety for MRI and/or CT imaging per the researcher s evaluation.

S. Individuals with hemoglobinopathies or severe asthma.

T. 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)


Information from the National Library of Medicine

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


Contacts
Contact: Andrew Keel, R.N. (301) 827-0324 akeel@cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nehal N Mehta, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02740699     History of Changes
Other Study ID Numbers: 160089
16-H-0089
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: June 8, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Cholesterol
Heart Disease
CT Scan
Crestor
Lipitor

Additional relevant MeSH terms:
Cardiovascular Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors