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
|Condition or disease|
|Heart Failure, Congestive|
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 Type :||Observational|
|Actual Enrollment :||579 participants|
|Official Title:||Vascular Stiffness and Pulmonary Congestion|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
- 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. ]
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|
|Principal Investigator:||William G. Hundley, MD||Wake Forest University Health Sciences|