Using Magnetic Resonance Imaging to Predict People Who Are Likely to Develop Flash Pulmonary Edema (The PREDICT Study)

Pulmonary edema is a condition in which an abnormal build-up of fluid occurs in the lungs,
which then leads to swelling. Symptoms include shortness of breath, breathing difficulty, and
coughing. Flash pulmonary edema, which develops suddenly and can be life-threatening, is
usually caused by heart failure. It occurs when the left ventricle of the heart is weakened
and does not function properly, potentially impeding the flow of blood from the heart to the
rest of the body. Blood pressure and fluid volume then increase, and excess blood accumulates
in the blood vessels and tissues of the lungs. Flash pulmonary edema requires immediate
treatment, including supplemental oxygen, mechanical ventilation, or medication. This study
will determine if a new form of MRI testing can be used to identify probable abnormalities in
blood flow to the lungs and predict increased risk of developing flash pulmonary edema among
older adults.

This study will enroll people who are at risk of developing flash pulmonary edema. At a
baseline study visit, participants will undergo a medical record review, a physical exam,
blood collection, questions about cardiovascular health, and an MRI stress test. For the
stress test, participants will first receive the medication dobutamine, which will increase
their heart rate and reduce the blood supply to their heart. Participants will then be placed
in an MRI machine and images of their heart will be taken. All participants will complete
follow-up cardiovascular health questionnaires three times a year for 1 to 10 years,
depending on when participants are enrolled into the study.

Inclusion Criteria:

- Participants must be diagnosed with one of the following conditions:

1. Diabetes with a fasting glucose level greater than or equal to 126 mg/dl and has
been receiving treatment for more than 5 years

2. High blood pressure with a history of a systolic blood pressure level greater
than 140 mm Hg and a diastolic blood pressure level greater than 85 mm Hg while
on medication

3. Coronary artery disease

Exclusion Criteria:

- Prior heart attack encompassing greater than 5% of the left ventricular mass (total MB
greater than 3 or Troponin I greater than 2)

- Heart attack, acute coronary syndrome (ACS), or angina within the 1 year prior to
study entry

- Medical inability to use any cardiovascular magnetic resonance device (e.g., implanted
electronic devices, intracranial metal, claustrophobia, closed angle glaucoma)

- Medically unable to receive dobutamine

- 3-vessel or left main coronary artery disease

- Moderate to severe valvular heart disease

- Left ventricular ejection fraction (LVEF) less than 25%

- History of pulmonary edema

- Serum creatinine level greater than 2.4 mg/dL or estimated glomerular filtration rate
(eGFR) less than 30 mL/min

- Use of an investigational drug or device within the 30 days prior to study entry

- Diagnosed with any systemic disease, including cancer, with a reduced life expectancy
of less than 12 months

- Chronic atrial fibrillation