Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

• Conditions: Myocardial Ischemia
• Interventions: Other: myocardial perfusion with magnetic resonance imaging

• Registration Number: NCT02723747
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-03-30
• Primary Completion: 2018-03
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	myocardial perfusion with magnetic resonance imaging	Healthy subjects with normal 12-lead electrocardiogram at rest.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Molecular Medicine and Surgery, Karolinska Institutet; 🇸🇪 Stockholm, Sweden