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NCT02723747 Clinical Trial

Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

Myocardial Ischemia Clinical Trial

Official title:
Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02723747
Other study ID # QUACK
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2016
Est. completion date December 2023

Study information
Verified date June 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 66
Est. completion date December 2023
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• myocardial perfusion with magnetic resonance imaging

Locations
Country Name City State
Sweden Department of Molecular Medicine and Surgery, Karolinska Institutet Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Through study completion, an average of 9 months
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