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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00542503
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
579
Enrollment
1
Location
78
Actual Duration (Months)
7.4
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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
    Actual Study Start Date :
    Jun 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    • Principal Investigator: William G. Hundley, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00542503
    Other Study ID Numbers:
    • 478
    • R01HL076438-01A2
    First Posted:
    Oct 11, 2007
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    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
    MRI
    Cardiac Stress Testing
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Sep 9, 2021