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i-Care; Quantitative-imaging in cardiac transthyretin amyloidosis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513310-36-01
Enrollment
64
Registered
2024-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin amyloid cardiomyopathy

Brief summary

Quantification of myocardial microcalcification on 18F-sodiumfluoride PET/CT and quantification of cardiac autonomic function on [123I]MIBG imaging.

Detailed description

Change in myocardial microcalcification activity and myocardial innervation on 18F-sodiumfluoride PET/CT and [123I]-MIBG respectively, Cardiac indices on magnetic resonance imaging, such as left ventricular ejection fraction, left ventricular mass, extracellular volume and global longitudinal strain, Cardiac biomarkers including NT-ProBNP and high-sensitivity cardiac troponin I, Clinical measures, such as 6MWT test, KCCQ-OS and Norfolk QOL‐DN

Interventions

DRUGRadio-Flu 0
DRUG1 - 4 GBq/ml oplossing voor injectie
DRUGMIBG (I123) 74 MBq/mL oplossing voor injectie Jobenguaan (123I)

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Change in myocardial microcalcification activity and myocardial innervation on 18F-sodiumfluoride PET/CT and [123I]-MIBG respectively, Cardiac indices on magnetic resonance imaging, such as left ventricular ejection fraction, left ventricular mass, extracellular volume and global longitudinal strain, Cardiac biomarkers including NT-ProBNP and high-sensitivity cardiac troponin I, Clinical measures, such as 6MWT test, KCCQ-OS and Norfolk QOL‐DN

Primary

MeasureTime frame
Quantification of myocardial microcalcification on 18F-sodiumfluoride PET/CT and quantification of cardiac autonomic function on [123I]MIBG imaging.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026