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出境医 / 临床实验 / Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.

Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.

Study Description
Brief Summary:
Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath).

Condition or disease Intervention/treatment Phase
Shortness of Breath Cardiac; Dyspnea Device: Exercise cardiac magnetic resonance imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : January 4, 2023
Estimated Study Completion Date : January 4, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Subjects with unexplained but suspected cardiac dyspnea
Subjects with unexplained but suspected cardiac dyspnea who are being scheduled for right heart catheterization will undergo an exercise cardiac magnetic resonance imaging (eCMR).
 Device: Exercise cardiac magnetic resonance imaging
Subjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging
Other Name: eCMR
Outcome Measures
Primary Outcome Measures :
  1. Ejection Fraction [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMR) reported in percentages

  2. Stroke Volume [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in mL

  3. Longitudinal Strain Assessment [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in percentages


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients aged ≥18 years years with suspected cardiac dyspnea who are scheduled to undergo right heart catheterization as dictated by a comprehensive examination and echocardiography will be included for enrollment.

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Mechanical ventilation
  • Acute or chronic renal failure (creatinine clearance <30 ml/min or requiring renal replacement therapy)
  • Inability to perform MRI (i.e. claustrophobia, severe obesity (>150 kg), device incompatible with MRI)
  • Inability to exercise
  • Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
  • Prior heart or lung transplantation
  • Left ventricular systolic (ejection fraction <50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
  • Significant left-sided valvular disease (≥moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery
Contacts and Locations

Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Brian P Shapiro Mayo Clinic
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE December 14, 2018
Estimated Primary Completion Date January 4, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Ejection Fraction [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMR) reported in percentages
  • Stroke Volume [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in mL
  • Longitudinal Strain Assessment [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in percentages
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
Official Title  ICMJE Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
Brief Summary Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Shortness of Breath
  • Cardiac; Dyspnea
Intervention  ICMJE Device: Exercise cardiac magnetic resonance imaging
Subjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging
Other Name: eCMR
Study Arms  ICMJE Experimental: Subjects with unexplained but suspected cardiac dyspnea
Subjects with unexplained but suspected cardiac dyspnea who are being scheduled for right heart catheterization will undergo an exercise cardiac magnetic resonance imaging (eCMR).
Intervention: Device: Exercise cardiac magnetic resonance imaging
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  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 4, 2023
Estimated Primary Completion Date January 4, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consecutive patients aged ≥18 years years with suspected cardiac dyspnea who are scheduled to undergo right heart catheterization as dictated by a comprehensive examination and echocardiography will be included for enrollment.

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Mechanical ventilation
  • Acute or chronic renal failure (creatinine clearance <30 ml/min or requiring renal replacement therapy)
  • Inability to perform MRI (i.e. claustrophobia, severe obesity (>150 kg), device incompatible with MRI)
  • Inability to exercise
  • Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
  • Prior heart or lung transplantation
  • Left ventricular systolic (ejection fraction <50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
  • Significant left-sided valvular disease (≥moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951779
Other Study ID Numbers  ICMJE 18-005354
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: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Shapiro, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian P Shapiro Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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