AzTrials
AzTrials

Myocardial IschemiaKAPSSNCT07548879

Quantitative Analysis of Cardiac Muscle Perfusion

A study testing Magnetic Resonance Imaging with Contrast in people with Myocardial Ischemia, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Ischemia
What is being tested?
Magnetic Resonance Imaging with Contrast
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteCzechia
Study dates
1 Jun 2026to 30 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Roman Panovský, MD contact

+420 543 18 2409

panovsky@fnusa.cz

Czechia1 site
  • St. Anne´s University Hospital Brno

    Brno, 60200

    Roman Panovský, MD, +420 543 18 2409, panovsky@fnusa.cz

    Roman Panovský, MD

Other trials in Czechia

About this study

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.

Read the detailed description

The aim of the study is to optimise the scanning and evaluation of stress perfusion with respect to the quantification of measurement results.

Cardiovascular diseases remain the leading cause of death among patients in developed countries. One of the most significant conditions within this group is ischemic heart disease (IHD), a state in which restricted blood flow through the coronary arteries results in myocardial ischemia.

At present, emphasis is placed on non-invasive diagnostic approaches to detect this condition. One such method is stress myocardial perfusion imaging.

Currently, this examination using magnetic resonance imaging (MRI) is mainly limited to qualitative assessment, in which the examiner evaluates perfusion defects based on a subjective visual assessment of myocardial blood flow, or semi-quantitative assessment, in which blood flow in individual myocardial segments is evaluated from the slope of signal-time curves. In this study, perfusion defects in individual segments will be assessed using quantitative analysis, i.e., direct calculation of blood flow in millilitres per gram of myocardial tissue, and the results will be compared with the aforementioned qualitative and semi-quantitative methods currently used in clinical practice.

In contrast, quantitative assessment of stress perfusion offers significant advantages, particularly the ability to provide an objective evaluation independent of the interpreting physician, improved diagnostic accuracy, and, importantly, the potential to diagnose patients with diffuse perfusion impairment across all vascular territories - for example, in those with three-vessel disease. However, fully quantified myocardial perfusion assessment is technically demanding and faces several limitations. The examination will be performed using a CE-marked Philips MRI system, with various frequencies and acquisition modules being evaluated.

The following quantitative CMR perfusion parameters will be analyzed:

Parameter Description Myocardial Blood Flow (MBF) Blood flow through the myocardium, expressed in ml/min/g of tissue. Measured for individual myocardial segments.

Myocardial Perfusion Reserve (MPR) Ratio of MBF during stress to MBF at rest: MPR = MBF_stress / MBF_rest, indicating the perfusion reserve.

Arterial Input Function (AIF) Contrast concentration in the left ventricle or aorta, serving as the reference input signal for MBF calculation.

Time to Peak (TTP) Time required for the myocardial signal to reach its maximum after bolus administration (indicator of delayed flow).

Upslope Slope of the rising phase of the perfusion curve - a relative measure of perfusion (often used in semi-quantitative analysis).

Peak Signal Intensity (PSI) Maximum signal value following contrast arrival (less commonly used as a standalone parameter).

Myocardial 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).

The MRI protocol monitors contrast agent passage through the myocardium and subsequent washout for at least one minute in selected cardiac slices (typically three parallel short-axis slices from the apex to the base of the left ventricle). During the examination, basic physiological parameters are continuously monitored, including ECG, blood pressure, oxygen saturation (pO₂), and respiration. If necessary, the stress effect of the administered agent can be immediately reversed by administration of, for example, aminophylline. During scanning, changes in contrast concentration (signal intensity) are tracked over time. A targeted perfusion sequence (Philips DYNs_BTFE_3sl) will be used. For quantification purposes, this sequence will be complemented by a very short labeling sequence, which enables quantitative calculations while leaving the dynamic and pharmacological characteristics of the main perfusion sequence unaffected. After the examination, quantitative parameters from the perfusion sequence will be calculated to obtain the required perfusion metrics.

Analysis of the main perfusion parameters and other common cardiovascular metrics will be performed using Philips IntelliSpace Portal and CVI42 software.

The objective of the project is to optimize the scanning and evaluation process of stress perfusion MRI towards full quantification of measurement results, through collaboration between the clinical site and the MRI system manufacturer.

Being tested
Magnetic Resonance Imaging with Contrast
Keywords
Fully quantitative stress perfusion, CMR
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance Imaging with ContrastDiagnostic test

    Myocardial 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).

Study groups in NCT07548879
Study groupRoleWhat they receive
Experimental ArmExperimentalPatients clinically indicated for non-invasive exclusion of ischemic heart disease (IHD) will be enrolled in the study. All participants will undergo stress myocardial perfusion MRI in accordance with ESC (European Society of Cardiology) guidelines. The examination will form part of a standard cardiac MRI protocol. During the procedure, a vasoactive agent will be administered as part of routine clinical care, in accord current standards and recommendations. A quantitative and semi-quantitative analysis of myocardial blood flow will be performed from the acquired data, and the results of both analyses will be compared. In patients with documented perfusion abnormalities, selective coronary angiography will be performed in accordance with standard clinical practice. In cases of inconclusive test results, an additional stress test (e.g., myocardial scintigraphy) or CT coronary angiography will be performed.
Receives: Diagnostic Test: Magnetic Resonance Imaging with Contrast

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day + up to 7 days after the examination

Secondary outcomes (2)
  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

    Measured: 1 day + up to 7 days after the indicated examination

  2. 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.

    Measured: 1 day + up to 7 days after the indicated examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07548879
Sponsor's protocol ID
20V/2025
Acronym
KAPSS
Status last verified
Apr 2026
First submitted
16 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Imaging with Contrast in people with Myocardial Ischemia, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roman Panovský, MD (+420 543 18 2409, panovsky@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The correlation between quantitative and semi-quantitative analyses (time frame: 1 day + up to 7 days after the examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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