Clinical trial NCT00542503: Using Magnetic Resonance Imaging to Predict People Who Are Likely to Develop Flash Pulmonary Edema (The PREDICT Study)
Official title: Vascular Stiffness and Pulmonary Congestion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Keywords: Cardiac Outcomes
MRI
Cardiac Stress Testing
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-10-11
Enrollment: 579
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with diabetes, high blood pressure, or coronary artery disease

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between MRI stress measures of cardiovascular stiffness and cardiovascular events
timeFrame: Participants will be followed by phone for 5 years and up to 10 years pending renewal.
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: William G. Hundley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stacey RB, Vera T, Morgan TM, Jordan JH, Whitlock MC, Hall ME, Vasu S, Hamilton C, Kitzman DW, Hundley WG. Asymptomatic myocardial ischemia forecasts adverse events in cardiovascular magnetic resonance dobutamine stress testing of high-risk middle-aged and elderly individuals. J Cardiovasc Magn Reson. 2018 Nov 22;20(1):75. doi: 10.1186/s12968-018-0492-5.
citation: Vasu S, Little WC, Morgan TM, Stacey RB, Ntim WO, Hamilton C, Thohan V, Chiles C, Hundley WG. Mechanism of decreased sensitivity of dobutamine associated left ventricular wall motion analyses for appreciating inducible ischemia in older adults. J Cardiovasc Magn Reson. 2015 Apr 8;17(1):26. doi: 10.1186/s12968-015-0131-3.
citation: Vasu S, Morgan TM, Kitzman DW, Bertoni A, Stacey RB, Hamilton C, Chiles C, Thohan V, Hundley WG. Abnormal stress-related measures of arterial stiffness in middle-aged and elderly men and women with impaired fasting glucose at risk for a first episode of symptomatic heart failure. J Am Heart Assoc. 2015 Jan 14;4(1):e000991. doi: 10.1161/JAHA.114.000991.
citation: Jeevanantham V, Chughtai H, Little WC, Morgan T, Kitzman DW, Hamilton CA, Hundley WG. Aging reduces left atrial performance during adrenergic stress in middle aged and older patients. Cardiol J. 2012;19(1):45-52. doi: 10.5603/cj.2012.0008.
citation: Chughtai HL, Morgan TM, Rocco M, Stacey B, Brinkley TE, Ding J, Nicklas B, Hamilton C, Hundley WG. Renal sinus fat and poor blood pressure control in middle-aged and elderly individuals at risk for cardiovascular events. Hypertension. 2010 Nov;56(5):901-6. doi: 10.1161/HYPERTENSIONAHA.110.157370. Epub 2010 Sep 13.