CT COMPARE: CT COronary Angiography to Measure PlAque REduction

  • STATUS
    Recruiting
Updated on 22 December 2020
statin therapy
hyperlipidemia
hmg-coa reductase inhibitors

Summary

The study is investigating how the amount of plaque in your arteries can be reduced by statin medication.

Researchers at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, are looking for volunteers to participate in a 36-month study.

  • There are no costs for study-related tests, procedures or medication.
  • For more information about this study you can access the NIH study page.

 

Description

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.

 

Details
Condition High Cholesterol (Hyperlipidemia)
Clinical Study IdentifierTX217973
Last Modified on22 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 45 yrs and 75 yrs?
Gender: Male or Female
Do you have High Cholesterol (Hyperlipidemia)?
You may be eligible if you are
Male between 45-75 years of age or
Female between 50-75 years of age
Willing to travel to the NIH for follow-up visits
On or eligible for statin therapy
Able to undergo a CT scan
You may NOT be eligible if you have
Kidney failure
The NIH Clinical Center, America’s Research Hospital, is located in Bethesda, Maryland on the Metro red line (Medical Center stop)
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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