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

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ClinicalTrials.gov Identifier: NCT00542503
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Flash pulmonary edema is a sudden, abnormal build-up of fluid in the lungs. It is usually caused by heart failure and can be life threatening. The purpose of this study is to determine if a new form of magnetic resonance imaging (MRI) can identify abnormal blood flow to the lungs and predict increased risk of developing flash pulmonary edema among older adults.

Condition or disease
Heart Failure, Congestive

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Stiffness and Pulmonary Congestion
Study Start Date : June 2007
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Heart Failure
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Association between MRI stress measures of cardiovascular stiffness and cardiovascular events [ Time Frame: Participants will be followed by phone for 5 years and up to 10 years pending renewal. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with diabetes, high blood pressure, or coronary artery disease

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542503

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: William G. Hundley, MD Wake Forest University Health Sciences
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00542503     History of Changes
Other Study ID Numbers: 478
R01HL076438-01A2 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Cardiac Outcomes
Cardiac Stress Testing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases