Validation of Myocardial Perfusion and Extracellular Volume Assessment Using Photon-Counting Computed Tomography (PCCT) Compared With Cardiac Magnetic Resonance (CMR) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorKarolinska University Hospital

About this trial

Cardiovascular diseases are the leading cause of death worldwide, responsible for about 30% of all deaths. This substantial burden highlights the need for accurate diagnostic tools that help doctors detect heart disease early and understand it more fully. Recent advances in medical imaging offer promising opportunities to improve how heart conditions are diagnosed and treated.

One important development in computed tomography (CT), a widely used imaging technique, is photon counting computed tomography (PCCT). PCCT produces clearer and more detailed images of the heart while using lower radiation doses and smaller amounts of contrast agent, the dye injected into the bloodstream to make body tissues more visible. As PCCT is still a relatively new technology, its full potential in clinical heart imaging has not yet been fully explored.

This study includes patients with narrowing of the aortic valve, a condition that reduces blood flow from the heart and often requires treatment. These patients undergo cardiac CT before receiving a minimally invasive valve replacement procedure called transcatheter aortic valve implantation (TAVI). The study evaluates two diagnostic applications of PCCT:

Functional assessment: Blood flow to the heart muscle is examined during stress imaging, when the heart works harder, to determine whether narrowed coronary arteries significantly limit blood supply.

Tissue characterization: The heart muscle is analyzed to detect scarring or fibrosis by measuring the extracellular volume (ECV), the space between cells.

If successful, PCCT could provide detailed anatomical, functional, and tissue information in a single non invasive examination, offering a "one stop shop" for comprehensive heart assessment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients referred for TAVI planning CTA. Both sexes are eligible; equal sex distribution is not required. Age ≥ 60 years.

Disqualifiers

None

Trial population

Patients with severe aortic valve stenosis referred for computed tomography angiography (CTA) as part of routine preprocedural evaluation for transcatheter aortic valve implantation (TAVI).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Stress myocardial perfusion imaging with PCCT. Extracellular volume quantification with PCCT.

    Diagnostic test

    Photon-counting cardiac CT including adenosine stress myocardial perfusion imaging and extracellular volume (ECV) quantification performed in patients undergoing TAVI evaluation. Results are compared with cardiac magnetic resonance and invasive coronary angiography.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Agreement Between Photon-Counting CT and Cardiac Magnetic Resonance for Extracellular Volume Quantification

Time frame
At baseline imaging assessment
2

Agreement Between Photon-Counting CT and Cardiac Magnetic Resonance for Myocardial Perfusion Assessment

Time frame
At baseline imaging assessment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

Karolinska Institutet

Collaborator