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

NCT00542503 | Completed DMC

• 2 other identifiers: 478R01HL076438-01A2
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Congestive

Keywords

Cardiac Outcomes; MRI; Cardiac Stress Testing

Outcome Measures

Primary Outcomes (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

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with diabetes, high blood pressure, or coronary artery disease

You may qualify if:

• Participants must be diagnosed with one of the following conditions:
• Diabetes with a fasting glucose level greater than or equal to 126 mg/dl and has been receiving treatment for more than 5 years
• 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
• Coronary artery disease

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• 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.

  PMID: 30463565 DERIVED

• 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.

  PMID: 25885436 DERIVED

• 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.

  PMID: 25589534 DERIVED

• 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.

  PMID: 22298167 DERIVED

• 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.

  PMID: 20837881 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• William G. Hundley, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 11, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (1)