CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction

NCT02740699 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: 16008916-H-0089
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Cholesterol; Heart Disease; CT Scan; Crestor; Lipitor

Outcome Measures

Primary Outcomes (1)

• Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography

  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%.

  Baseline and 24 months

Secondary Outcomes (5)

• 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

• Linear Mixed-effects Regression Coefficient of Age Effect on Plaque Volume

  Baseline, 24 months and 36 months

• 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 Race Effect on Plaque Volume (Beta Coefficient)

  Baseline, 24 months and 36 months

• Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume

  Baseline, 24 months and 36 months

Study Arms (1)

Moderate to High Statin Treatment in Participants with Coronary Artery Plaque

OTHER

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.

Drug: Rosuvastatin; Drug: Atorvastatin; Radiation: Cardiac Computed Tomography (CT); Radiation: Cardiac Magnetic Resonance Image (MRI)

Interventions

Rosuvastatin DRUG

Participants will receive 20-40 mg once daily

Also known as: Crestor

Moderate to High Statin Treatment in Participants with Coronary Artery Plaque

Atorvastatin DRUG

Participants will receive 40-80 mg once daily.

Also known as: Lipitor

Moderate to High Statin Treatment in Participants with Coronary Artery Plaque

Cardiac Computed Tomography (CT) RADIATION

Cardiac CT angiography (CCTA) provides a non-invasive method of evaluating both calcified and noncalcified plaque volume. Performed at baseline, 12 months 24 months, and 36 months.

Also known as: Cardiac CT angiography (CCTA)

Moderate to High Statin Treatment in Participants with Coronary Artery Plaque

Cardiac Magnetic Resonance Image (MRI) RADIATION

Provides a non-invasive method of evaluating both calcified and noncalcified plaque volume. Cardiac MRI may be performed at baseline, and 24 months (optional).

Also known as: Cardiovascular Magnetic Resonance Imaging (CMR)

Moderate to High Statin Treatment in Participants with Coronary Artery Plaque

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. 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
• 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
• 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
• 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).

You may not qualify if:

• 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 stroke or TIA
• F. Physician-diagnosed heart failure
• G. Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
• H. Active treatment for cancer
• I. Prior hypersensitivity reaction to iodinated contrast injection
• J. Known hyperthyroidism.
• K. Acute renal failure, renal transplant, dialysis and renal failure clinically diagnosed.
• L. History of liver transplant or severe liver disease or unexplained elevation of baseline ALT\>3x upper limit of normal
• M. Pregnancy and nursing
• N. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial.
• O. Any other conditions that precludes safety for MRI and/or CT imaging per the researcher's evaluation.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 23206978 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.

  PMID: 22883507 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.

  PMID: 24239923 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases

Interventions

Rosuvastatin Calcium; Atorvastatin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

Protocol was terminated early due to departure of Principal Investigator.

Results Point of Contact

• Title: Dr. Marcus Chen
• Organization: National Heart, Lung, and Blood Institute at the National Institutes of Health

chenmy@nhlbi.nih.gov

301.496.0077

Study Officials

• Nehal N Mehta, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 15, 2016
• Study Start: April 11, 2016
• Primary Completion: January 27, 2022
• Study Completion: March 11, 2022
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2022-03

Locations

US (1)