Quantitative Analysis of Cardiac Muscle Perfusion
ConditionMyocardial Ischemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Anne's University Hospital Brno, Czech Republic
About this trial
Full quantitative perfusion of the myocardial wall using MRI is a difficult method for several reasons. First the perfusion algorithm is mostly only relatively available, usually available algorithms /e.g. ISP/ shows not precise results according to our measurements, secondly based on signal physics and nature of MRI scans is not easy to get absolute numbers and specific new algorithms must be developed and tested. Such a tool is not only needed for some special cohort of patients, like 3-vessel disease, coronary artery disease or diffuse coronary artery involvement in coronary vasculopathy in patients after heart transplantation. Fully quantitative perfusion analysis is highly needed for nearly all cardiac patients to better characterise the health and status of the myocardium.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Patients indicated for a non-invasive test for ischemic heart disease/chronic coronary syndrome
Patients with intermittent chest pain and low to moderate probability of chronic coronary syndrome
Disqualifiers
Presence of relative or absolute contraindications to stress testing, including acute coronary syndrome, life-threatening arrhythmias, severe chronic obstructive pulmonary disease (COPD), or second- or third-degree atrioventricular (AV) block.
Contraindications to MRI, such as severe claustrophobia, presence of ferromagnetic material or implants, or severe renal impairment.
Trial design
Design model
Single group
Treatments tested in this trial
Magnetic Resonance Imaging with Contrast
Diagnostic testMyocardial perfusion will be conducted according to the standard ESC perfusion protocol, using Gadolinium-based contrast agent (Gadovist) at a dose of 0.1 mmol/kg (0.1 ml/kg) administered at 3-5 ml/s, followed by 20 ml of saline flush. The contrast agent will be divided into two equal doses for stress and rest perfusion (0.05 ml/kg per perfusion). The stress agents used will be Adenosine (short-term infusion at 140 µg/kg/min using an infusion pump) or Regadenoson (400 µg intravenous bolus). Patients with relative or absolute contraindications to stress testing will be excluded from the study, including those with acute coronary syndrome, life-threatening arrhythmias, severe COPD, second- or third-degree AV block, and patients with contraindications to MRI (ferromagnetic implants, severe renal failure, pregnancy).
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Experimental ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The correlation between quantitative and semi-quantitative analyses
The primary outcome measure is the degree of correlation between quantitative and semi-quantitative analyses of rest and stress myocardial perfusion assessed by magnetic resonance imaging (MRI), evaluated both globally and in individual myocardial segments.
Time frame
1 day + up to 7 days after the examinationSecondary outcomes
1
Ratio between MBF during stress and rest
Degree of correlation between quantitative analysis parameters: Myocardial Blood Flow (MBF) in ml/min/g for each myocardial segment and Myocardial Perfusion Reserve (MPR) as ratio between MBF during stress and rest - MPR = MBF\_stress / MBF\_rest with already established semiquantitive parameters: Time to Peak (TTP) as time for the myocardial signal to reach peak after contrast bolus (indicator of low blood flow), Upslope as the slope of signal intensity increase in signal intensity to time curve of the myocardium and Peak Signal Intensity (PSI) as the maximal signal intensity reached after contrast agent bolus
Time frame
1 day + up to 7 days after the indicated examination2
The predictive value of quantitative and semi-quantitative MRI perfusion
The secondary outcome measure is the predictive value of quantitative and semi-quantitative MRI perfusion results relative to findings from invasive coronary angiography and other functional stress tests.
Time frame
1 day + up to 7 days after the indicated examinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Anne's University Hospital Brno, Czech Republic
Lead sponsor
Philips Medical Systems
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: