4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / MRI Assessment of Pulmonary Edema in Acute Heart Failure (MAP-AHF)

MRI Assessment of Pulmonary Edema in Acute Heart Failure (MAP-AHF)

Study Description
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.

Condition or disease Intervention/treatment
Acute Heart Failure Pulmonary Edema With Heart Failure Diagnostic Test: MRI

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.

Study Design
Layout table for study information
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
Arms and Interventions
Group/Cohort Intervention/treatment
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.

Outcome Measures
Primary Outcome Measures :
  1. Magnitude of lung water density measured with MRI at Hospital Admission [ Time Frame: Baseline (hospital admission) ]
    Lung water density (0-100%) is the fraction of lung tissue that contains water

  2. Difference in lung water density measured with MRI at hospital admission and hospital discharge [ Time Frame: 7 days ]
    Absolute change in lung water density from baseline (hospital admission) to hospital discharge. Lung water density will be 0%-100% at each time point.

  3. Number and timing of clinical events and their statistical association with Outcome 1 (Magnitude of lung water density measured with MRI at Hospital Admission) [ Time Frame: Up to 5 years ]
    Clinical events include cardiovascular hospitalization, cardiovascular emergency department visits or death

  4. Number and timing of clinical events and their statistical association with Outcome 2 (Difference in lung water density measured with MRI at hospital admission and hospital discharge) [ Time Frame: Up to 5 years ]
    Clinical events include cardiovascular hospitalization, cardiovascular emergency


Eligibility Criteria
Layout table for eligibility information
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
Study Population
Patients admitted to hospital with a diagnosis of acute heart failure
Criteria

Inclusion Criteria:

  • 18 years of age or older and willing/able to provide informed consent
  • patients being treated for acute heart failure (including those patients with both reduced and preserved ejection fraction)
  • patients receiving medical therapy for pulmonary edema by current standard of care (including oral or IV diuretics)
  • patients identified within 48 hours of initiation of medical therapy for pulmonary edema, defined as the time of first diuretic (IV or PO) or escalation of existing diuretic therapy administered within the ED or hospital

Exclusion Criteria:

  • contraindication to MRI
  • patient too critically ill/unstable as per the clinical care team for transport to MRI scanner within the required scanning window
  • moderate to severe dementia
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Richard Thompson, PhD 7804928665 richard.thompson@ualberta.ca
Contact: Karin Kushniruk, RN, PhD 7804928476 karin.kushniruk@ualberta.ca

Locations
Layout table for location information
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Richard Thompson, PhD    7804928665    richard.thompson@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Tracking Information
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
 (submitted: June 25, 2019)
  • Magnitude of lung water density measured with MRI at Hospital Admission [ Time Frame: Baseline (hospital admission) ]
    Lung water density (0-100%) is the fraction of lung tissue that contains water
  • Difference in lung water density measured with MRI at hospital admission and hospital discharge [ Time Frame: 7 days ]
    Absolute change in lung water density from baseline (hospital admission) to hospital discharge. Lung water density will be 0%-100% at each time point.
  • Number and timing of clinical events and their statistical association with Outcome 1 (Magnitude of lung water density measured with MRI at Hospital Admission) [ Time Frame: Up to 5 years ]
    Clinical events include cardiovascular hospitalization, cardiovascular emergency department visits or death
  • Number and timing of clinical events and their statistical association with Outcome 2 (Difference in lung water density measured with MRI at hospital admission and hospital discharge) [ Time Frame: Up to 5 years ]
    Clinical events include cardiovascular hospitalization, cardiovascular emergency
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Acute Heart Failure
  • Pulmonary Edema With Heart Failure
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.
Study Groups/Cohorts Single Arm
Intervention: Diagnostic Test: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 25, 2019)
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:

  • 18 years of age or older and willing/able to provide informed consent
  • patients being treated for acute heart failure (including those patients with both reduced and preserved ejection fraction)
  • patients receiving medical therapy for pulmonary edema by current standard of care (including oral or IV diuretics)
  • patients identified within 48 hours of initiation of medical therapy for pulmonary edema, defined as the time of first diuretic (IV or PO) or escalation of existing diuretic therapy administered within the ED or hospital

Exclusion Criteria:

  • contraindication to MRI
  • patient too critically ill/unstable as per the clinical care team for transport to MRI scanner within the required scanning window
  • moderate to severe dementia
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Richard Thompson, PhD 7804928665 richard.thompson@ualberta.ca
Contact: Karin Kushniruk, RN, PhD 7804928476 karin.kushniruk@ualberta.ca
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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