Myocardial Perfusion and Tissue Characterization with Photon-Counting CT in TAVI Patients
Official title: Validering av genomblödning Och extracellulärvolym i hjärtmuskeln Med datortomografiundersökning Hos Patienter Som Ska genomgå Perkutan Aortaklaffbyte (TAVI)
Run by Karolinska University Hospital · NCT07799363 · Data updated 2026-11-12
This study tests whether photon-counting CT can measure heart blood flow and tissue properties as well as MRI in patients planning a TAVI procedure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Huddinge, Stockholm County) |
| Status | Recruiting |
| Started | June 10, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07799363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 60 or older referred for TAVI planning who can safely undergo PCCT and MRI imaging per study criteria.
✕Probably not a fit
Patients with significant contrast or renal contraindications, certain arrhythmias, or incompatible implants may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares photon-counting CT measurements of myocardial perfusion and extracellular volume with cardiac MRI in adults aged 60 and older who are being evaluated for transcatheter aortic valve implantation. It uses stress-induced perfusion imaging and extracellular volume quantification with PCCT to explore the technique’s accuracy and potential to reduce radiation and contrast exposure. The aim is to determine whether PCCT can provide reliable, MR-comparable information about myocardial perfusion and fibrosis in a routine TAVI work-up. Enrollment is limited to patients referred for TAVI planning at Karolinska University Hospital, with careful screening for contraindications to imaging contrast and other device-related exclusions. Findings will inform feasibility of PCCT as an alternative imaging modality in this population.
Why it matters
Potential benefit: If successful, PCCT could offer accurate heart imaging with lower radiation and contrast exposure for patients undergoing TAVI planning.
How similar studies have gone: Prior work in MR and CT perfusion imaging supports feasibility of cross-modality comparisons, but this specific PCCT vs MRI approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Karolinska University Hospital
Huddinge, Stockholm County, Sweden Recruiting
Study contacts
- Study coordinator: Yousuf Zakko, MD, PhD student
- Email: yousuf.zakko@regionstockholm.se
- Phone: +46 8-123 819 11
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.