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NCT Number: NCT07799363

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)

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Huddinge, Stockholm County, 141057, Sweden

Location status: Recruiting

Location contact

Peter Lindholm, MD, PhD

CONTACT

[email protected]

+46 70-297 64 26

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hemodynamic or rhythm related conditions: Systolic blood pressure < 90 mmHg. Bradycardia: < 45 beats/min. Persistent AV block II-III. Sick sinus syndrome. Prolonged QT interval. Atrial fibrillation. Severe heart failure: NYHA class IV.

Contrast or kidney relaterad factors: Previous allergic reaction to iodinated or gadolinium contrast or history of contrast induced nephropathy. Impaired renal function: eGFR < 45 mL/min/1.73 m².

Implants or devices: Metallic implants or devices in the imaging area, e.g., pacemaker. Medication: Persantin (dipyridamole), Theophyllamine, Fevarin (fluvoxamine).

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Raquel Themudo, MD, PhD

CONTACT

[email protected]

+46 8-123 808 27

Yousuf Zakko, MD, PhD student

CONTACT

[email protected]

+46 8-123 819 11

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Validering av genomblödning Och extracellulärvolym i hjärtmuskeln Med datortomografiundersökning Hos Patienter Som Ska genomgå Perkutan Aortaklaffbyte (TAVI)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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