About this trial
This study aims to identify and assess new CMR techniques that can improve current CMR protocols.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: > 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system
Disqualifiers
General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.Regular nicotine consumption during the last 6 months
Age: >18 y, Informed consent, Clinically indicated CMR exam
General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.
Trial population
The study population will be composed of patients with suspected cardiovascular disease who are scheduled for a clinical CMR scan as part of a routine clinical work-up. Patients will be stratified according to the clinical indication for CMR and their suspected or known clinical diagnosis.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary diagnosis comparison between SMART CMR and standard CMR
(All patients) Agreement of the suggested primary diagnosis derived from SMART CMR, compared with the diagnosis established from standard CMR protocols, using the final clinical diagnosis as established by the treating physician, as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR protocol will be used as the standard of truth.
Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease
(Patients with suspected coronary artery disease:) Agreement of the main finding regarding the presence of a coronary territory at risk for inducible myocardial ischemia myocardial derived from OS-CMR, compared with standard first-pass perfusion CMR, using the coronary angiography report as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR first pass perfusion scan will be used as the standard of truth.
Secondary outcomes
SMART CMR scan completion percentage
Proportion of SMART CMR scans that could be completed according to the protocol
OS-CMR scan completion percentage
Proportion of OS-CMR scans that could be completed according to the protocol
Adverse event monitoring during SMART CMR sequences
Number and proportion of reported adverse events effects during SMART CMR
Adverse event monitoring during OS-CMR sequence
Number and proportion of reported adverse events during OS-CMR
Sponsors and contacts
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