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Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

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ClinicalTrials.gov Identifier: NCT02723747
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Ugander, Karolinska Institutet

Tracking Information
First Submitted Date March 16, 2016
First Posted Date March 30, 2016
Last Update Posted Date October 10, 2017
Study Start Date March 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2016)
Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g) [ Time Frame: Through study completion, an average of 9 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02723747 on ClinicalTrials.gov Archive Site
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 Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
Official Title Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
Brief Summary The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.
Detailed Description Cardiac magnetic resonance (CMR) imaging is a wide available technique for the diagnosis of myocardial ischemia. However, myocardial first-pass perfusion evaluation has been limited due to the moderate accuracy of the currently available qualitative and semiquantitative methods used to assess myocardial perfusion, and due to the lack of efficient absolute quantitative methods. Some CMR techniques and post-processing mathematical models have been developed for quantitative measurement of myocardial blood flow reserve with perfusion CMR under pharmacological stress. Measurement of these parameters with CMR have been shown to increase the accuracy of CMR in diagnosing myocardial ischemia, but most of these methods present technical challenges and have unreasonably time consuming post-processing. The aim of this study is to validate a full automated post-processing software for first pass perfusion CMR images that results in automated generated quantitative perfusion color maps.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).
Condition Myocardial Ischemia
Intervention Other: myocardial perfusion with magnetic resonance imaging
Study Groups/Cohorts Healthy volunteers
Healthy subjects with normal 12-lead electrocardiogram at rest.
Intervention: Other: myocardial perfusion with 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 Recruiting
Estimated Enrollment
 (submitted: March 29, 2016)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • healthy individuals with normal 12-lead electrocardiogram at rest.

Exclusion Criteria:

  • systolic blood pressure below 90 mmHg;
  • bradycardia (< 45 heart beats/minute);
  • intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination;
  • impaired renal function assessed by venous blood sample.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jenny Rasck, BMA jenny.rasck@karolinska.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02723747
Other Study ID Numbers QUACK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Martin Ugander, Karolinska Institutet
Study Sponsor Karolinska Institutet
Collaborators Not Provided
Investigators
Principal Investigator: Martin Ugander, MD, PhD Department of Molecular Medicine and Surgery, Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date October 2017