Condition or disease | Intervention/treatment |
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Acute Heart Failure Pulmonary Edema With Heart Failure | Diagnostic Test: MRI |
Heart failure is a condition where the heart is unable to pump enough blood to meet the body's needs and Acute Heart Failure is a sudden worsening of this condition. It is associated with many symptoms but most commonly includes shortness of breath due to pulmonary edema (or increased "lung water").
A physical exam and chest x-ray are commonly used to diagnose AHF and estimate the amount of increased lung water in patients with AHF. This study will use images from MRI (Magnetic Resonance Imaging) scans to obtain a more accurate measurement of the increased lung water in AHF patients. Lung water will be measured via MRI at hospital admission and discharge to find out the change in lung water over the course of hospitalization and treatment. The investigators will collect NT-proBNP and perform a chest x-ray upon hospital admission and again upon discharge, if not already done as part of usual care. The investigators will follow medical records for one year after hospitalization to see if the accurate lung water measurements obtained in hospital can predict long term outcomes. This is a single-centre project and a total of 300 patients will be recruited to participate.
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | MRI Assessment of Pulmonary Edema in Acute Heart Failure |
Actual Study Start Date : | January 2, 2019 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | June 1, 2024 |
Group/Cohort | Intervention/treatment |
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Single Arm |
Diagnostic Test: MRI
MRI studies (non-contrast) will consist of a free-breathing localizer (~10 seconds) followed by a free-breathing yarnball water density scan, for a total MRI time of < 3 minutes.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard Thompson, PhD | 7804928665 | richard.thompson@ualberta.ca | |
Contact: Karin Kushniruk, RN, PhD | 7804928476 | karin.kushniruk@ualberta.ca |
Canada, Alberta | |
University of Alberta | Recruiting |
Edmonton, Alberta, Canada | |
Contact: Richard Thompson, PhD 7804928665 richard.thompson@ualberta.ca |
Tracking Information | |||||||||
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First Submitted Date | May 22, 2019 | ||||||||
First Posted Date | June 26, 2019 | ||||||||
Last Update Posted Date | January 7, 2020 | ||||||||
Actual Study Start Date | January 2, 2019 | ||||||||
Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | MRI Assessment of Pulmonary Edema in Acute Heart Failure | ||||||||
Official Title | MRI Assessment of Pulmonary Edema in Acute Heart Failure | ||||||||
Brief Summary | Researchers are testing a more accurate way to measure how much fluid is in the lungs (also called pulmonary edema, or "increased lung water") in people with Heart Failure (HF) using MRI (Magnetic Resonance Imaging). There is little known about the exact level of lung water in patients with AHF or how these levels change from the time of hospital admission to discharge. The purpose of this research study is to measure the lung water in patients hospitalized for HF, to determine the change in lung water over the course of hospitalization and treatment, and to find out if lung water levels can predict if patients are higher or lower risk for returning to the hospital or dying from heart failure. | ||||||||
Detailed Description |
Heart failure is a condition where the heart is unable to pump enough blood to meet the body's needs and Acute Heart Failure is a sudden worsening of this condition. It is associated with many symptoms but most commonly includes shortness of breath due to pulmonary edema (or increased "lung water"). A physical exam and chest x-ray are commonly used to diagnose AHF and estimate the amount of increased lung water in patients with AHF. This study will use images from MRI (Magnetic Resonance Imaging) scans to obtain a more accurate measurement of the increased lung water in AHF patients. Lung water will be measured via MRI at hospital admission and discharge to find out the change in lung water over the course of hospitalization and treatment. The investigators will collect NT-proBNP and perform a chest x-ray upon hospital admission and again upon discharge, if not already done as part of usual care. The investigators will follow medical records for one year after hospitalization to see if the accurate lung water measurements obtained in hospital can predict long term outcomes. This is a single-centre project and a total of 300 patients will be recruited to participate. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients admitted to hospital with a diagnosis of acute heart failure | ||||||||
Condition |
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Intervention | Diagnostic Test: MRI
MRI studies (non-contrast) will consist of a free-breathing localizer (~10 seconds) followed by a free-breathing yarnball water density scan, for a total MRI time of < 3 minutes.
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Study Groups/Cohorts | Single Arm
Intervention: Diagnostic Test: MRI
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
300 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | June 1, 2024 | ||||||||
Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03999138 | ||||||||
Other Study ID Numbers | Pro00091033 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Richard Thompson, University of Alberta | ||||||||
Study Sponsor | University of Alberta | ||||||||
Collaborators | Canadian Institutes of Health Research (CIHR) | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | University of Alberta | ||||||||
Verification Date | January 2020 |