Quantitative Analysis of Cardiac Muscle Perfusion

NCT07548879 | Not Yet Recruiting

• 1 other identifier: 20V/2025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Ischemia

Keywords

Fully quantitative stress perfusion; CMR

Outcome Measures

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.

  1 day + up to 7 days after the examination

Secondary Outcomes (2)

• Ratio between MBF during stress and rest

  1 day + up to 7 days after the indicated examination

• The predictive value of quantitative and semi-quantitative MRI perfusion

  1 day + up to 7 days after the indicated examination

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Patients 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.

Diagnostic Test: Magnetic Resonance Imaging with Contrast

Interventions

Magnetic Resonance Imaging with Contrast DIAGNOSTIC_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).

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Philips Medical Systems: collaborator

Study Sites (1)

St. Anne´s University Hospital Brno

Brno, 60200, Czechia

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Roman Panovský, MD

  St. Anne's University Hospital Brno, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Panovský, MD

CONTACT

+420 543 18 2409; panovsky@fnusa.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)