Clinical trial NCT02723747: Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
Official title: Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Keywords: myocardial ischemia
magnetic resonance imaging
perfusion
software
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Molecular Medicine and Surgery, Karolinska Institutet
Study officials:
affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet
name: Martin Ugander, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nickander J, Themudo R, Thalen S, Sigfridsson A, Xue H, Kellman P, Ugander M. The relative contributions of myocardial perfusion, blood volume and extracellular volume to native T1 and native T2 at rest and during adenosine stress in normal physiology. J Cardiovasc Magn Reson. 2019 Nov 25;21(1):73. doi: 10.1186/s12968-019-0585-9.