Heart Failure, CongestivePREDICTNCT00542503
Using Magnetic Resonance Imaging to Predict People Who Are Likely to Develop Flash Pulmonary Edema (The PREDICT Study)
An observational study of Heart Failure, Congestive, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Heart Failure, Congestive
- How many people
- 579 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2007to 1 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with diabetes, high blood pressure, or coronary artery disease
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Vascular Stiffness and Pulmonary Congestion
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.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Keywords
- Cardiac Outcomes, MRI, Cardiac Stress Testing
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between MRI stress measures of cardiovascular stiffness and cardiovascular events
Measured: Participants will be followed by phone for 5 years and up to 10 years pending renewal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study start1 Jun 2007
- Primary completion1 Dec 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William G. Hundley, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542503
- Sponsor's protocol ID
- 478
- Other IDs
- R01HL076438-01A2
- Acronym
- PREDICT
- Status last verified
- Sep 2021
- First submitted
- 5 Oct 2007
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30463565Vasu 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.
PubMed 25885436Vasu 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.
PubMed 25589534Jeevanantham 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.
PubMed 22298167Chughtai 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.
PubMed 20837881
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Stiffness and Pulmonary Congestion
- ClinicalTrials.gov ID
- NCT00542503
- Acronym / sponsor ID
- PREDICT / 478
- Conditions
- Heart Failure, Congestive
- Keywords
- Cardiac Outcomes, MRI, Cardiac Stress Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with diabetes, high blood pressure, or coronary artery disease
Key inclusion criteria (4 listed)
- Participants must be diagnosed with one of the following conditions:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 30463565Stacey 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.
- Derived from this study: PubMed 25885436Vasu 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.
- Derived from this study: PubMed 25589534Vasu 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.
- Derived from this study: PubMed 22298167Jeevanantham 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.
- Derived from this study: PubMed 20837881Chughtai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G. Hundley, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00542503, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.