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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Wake Forest Baptist Health
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gregory Hundley, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00542503
First received: October 5, 2007
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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
Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Stiffness and Pulmonary Congestion

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 608
Study Start Date: June 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542503

Contacts
Contact: Sandra T. Soots, RN, CCRC 336-716-7035 ssoots@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Sandra T. Soots, RN, CCRC    336-716-7035    ssoots@wfubmc.edu   
Principal Investigator: William G. Hundley, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: William G. Hundley, MD Wake Forest School of Medicine
  More Information

No publications provided by Wake Forest Baptist Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Hundley, Principal Investigator, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00542503     History of Changes
Other Study ID Numbers: 478, R01HL076438-01A2, R01 HL076438-01A2
Study First Received: October 5, 2007
Last Updated: February 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
Cardiac Outcomes
MRI
Cardiac Stress Testing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014