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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

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.

Condition or disease Intervention/treatment
Myocardial Ischemia Other: myocardial perfusion 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
Healthy volunteers
Healthy subjects with normal 12-lead electrocardiogram at rest.
Other: myocardial perfusion with magnetic resonance imaging



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723747


Contacts
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Contact: Jenny Rasck, BMA jenny.rasck@karolinska.se

Locations
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Sweden
Department of Molecular Medicine and Surgery, Karolinska Institutet Recruiting
Stockholm, Sweden, 171 76
Contact: Jenny Rasck, BMA       jenny.rasck@karolinska.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Martin Ugander, MD, PhD Department of Molecular Medicine and Surgery, Karolinska Institutet

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Responsible Party: Martin Ugander, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02723747     History of Changes
Other Study ID Numbers: QUACK
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Martin Ugander, Karolinska Institutet:
myocardial ischemia
magnetic resonance imaging
perfusion
software

Additional relevant MeSH terms:
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Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases