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.

Conditions

• Cardiovascular Disease

Interventions

DRUG

Rosuvastatin

Participants will receive 20-40 mg once daily

DRUG

Atorvastatin

Participants will receive 40-80 mg once daily.

RADIATION

Cardiac Computed Tomography (CT)

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.

RADIATION

Cardiac Magnetic Resonance Image (MRI)

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

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

• Nehal N Mehta, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-11

Primary Completion

2022-01-27

Completion

2022-03-11

FDA Drug

Yes

Countries

• United States

Study Locations