About The Study

Who runs this study?

The Section of Inflammation and Cardiometabolic Diseases within the Cardiovascular Pulmonary Branch of the National Heart, Lung and Blood Institute (NHLBI) will conduct this study.

The Principal Investigator of this study is Nehal Mehta, MD MSCE FAHA, a preventive cardiologist. He is Chief of the Section of Inflammation and Cardiometabolic Diseases at the NHLBI.

What is this study about?

In this study, our goal is to inform patients about their psoriasis, risk for heart disease and diabetes. We will follow patients over the 4 year study and provide cardiovascular care including imaging tests, blood tests and specialized studies of their metabolism.

What kind of commitment is involved?

Initial visit: If interested in participating in the study, you will be asked to come to NIH for your initial screening visit for:

  • Comprehensive cardiovascular evaluation including a history and physical by a cardiologist including tests to assess for heart disease and diabetes
  • Research blood draw and urine collection
  • Obtaining a small amount of skin and fat tissue
  • Baseline cardiovascular imaging including inflammation scans (FDG PET) and coronary scans (CCTA)

However, if you prefer not to participate in all of the study procedures, you can be evaluated at the screening visit and permitted to participate in any of the study procedures to which you consent. You will not however be followed beyond the screening visit if you choose not to participate in the imaging studies.

Return visit: The number of outpatient visits will not exceed 4 within a given year, and will be customized to the individual person if not all study procedures are completed within the first admission. Most participants will return 1 year after first their visit and then yearly thereafter.

Return Visit during a 'Flare' of Psoriasis: Visits may occur if you experience a 'flare' of your psoriasis - a certain percentage increase in the skin severity of the disease - defined by your dermatologist or reported by you to our study team and then confirmed by a physician. Your blood, tissue and imaging will be collected again during this return visit.

How can I ask questions or ask for help?

Email us at mansi.mehta2@nih.gov or at tania.machado@nih.gov.
We will respond within 5 business days.

IMAGING STUDIES

On the morning of your scans, please do not eat or drink for 4 hours before your schedule PET/CT and PET/MRI.

These procedures will allow us to determine the metabolic activity of various parts of your body, including different types of fat tissue. It will also show us areas in your body that have inflammation.

  1. Positron emission tomography/computed tomography (PET/CT):
    On the morning of your scans, you will have an intravenous (IV) line placed in your arm to allow the radioactive sugar, called 18FDG (18 fluorodeoxyglucose), to be injected into the IV. We will also test your blood sugar with a fingerstick before the injection and scan.
  2. After the FDG is injected, you will rest quietly in a room for 60 minutes before the scan is performed. This will allow the FDG to move through your body.

    Then you will be asked to lay flat on a special bed that will move in and out of the PET/CT scanner. This is not an enclosed scanner.

    You will be in the PET/CT scanner for about 40 minutes.

  3. Positron emission tomography/magnetic resonance imaging (PET/MRI):
  4. If you are able to have the PET/MRI performed, this procedure will immediately follow the PET/CT so that we can utilize the same dose of radioactive sugar to keep radiation as low as possible. You will be transported directly from the CT department to the MRI department.

    You will be asked again to lay flat on a special bed. The staff will place a device on your body to help keep you from moving. You will also be asked to wear a face mask which will allow us to obtain the highest quality images.

    You will be in the PET/MRI scanner for about 60 minutes. Liquids without caffeine can be taken after PET scanning.

  5. Coronary CT Angiogram:
  6. The coronary CT angiogram is a noninvasive test that uses x-rays to make pictures of your heart and vessels. It has the ability to diagnose whether or not you have coronary heart disease, the leading cause of a heart attack. You will be given IV contrast dye to help take these pictures. If you have a shellfish or iodine allergy, please tell the research nurse as we may have to prepare you for the scan with a medication called prednisone.

    First, we will obtain a baseline electrocardiogram (EKG) for your heart rate. If your heart rate is above 60, you maybe given medications to slow your heart rate, including a beta blocker or calcium channel blocker. These medications are short-acting and will not stay in your system much longer than your stay at the NIH. You may also be given a medication called nitroglycerin under your tongue. This short-acting medication will enlarge your heart vessels to improve the quality of the pictures taken by the scanner.

    During the coronary CT angiogram, you will be asked to hold your breath for about 5-10 seconds at a time. Your blood pressure and heart rhythm will be checked periodically during the procedure to understand any effects the medications given for the test may have on you.

    You will be in the CT scanner for about 15 minutes.

BIOPSIES

Skin biopsy:

A piece of skin will be taken from 2 sites: an area without psoriasis (ideally, the buttocks), and an area with active psoriasis. Before the skin biopsy, your skin will be cleaned with an antiseptic solution and numbed with a medication called lidocaine.

Using a pencil-type tool, we will collect the 2 skin samples. Each sample will be slightly larger than the size of a pencil eraser head.

Fat (adipose) biopsy:

Once the small skin sample has been removed in the area without psoriasis, the doctor will give you additional lidocaine to the buttocks in order to ensure that the area is numb and you do not feel any pain. The ideal place for the fat biopsy is in the buttocks as this allows direct and easy access to fat tissue.

The doctor will then insert a tool used for liposuction under your skin to obtain fat tissue. You may feel some pressure and vibration, but you should not feel pain.

After this procedure is complete, the skin biopsy site will be closed with two to three non-dissolvable stitches and covered with a bandage. The stitches will need to be removed by a medical practitioner (nurse or doctor) within 10-14 days. This can be a provider near your home or you may schedule an appoitment with us. During this time, you will not be able to submerge the wound (baths, swimming, hot tubs) or perform strenuous activity (long distance running, biking, heavy lifting over 15lbs, etc.). You will be able to shower normally starting 24 hours after your biopsies.

PHOTOGRAPHY

You will be asked to take photographs of parts of your body with and without psoriasis so that we can document and follow your skin disease over time.