NCT05776212|Recruiting
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
I-CARE
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I-CARE
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
observational
140
1 country
1
Study Start
August 25, 2021
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM. Hypotheses:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2021
Actual (reported)January 26, 2023
Actual (reported)March 20, 2023
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
TBR threshold
Tissue to background ratio with a good specificity and sensitivity to differentiatie subjects with ATTR-CM from subjects with phenocopies.
1.5 years
Change in TBR
2.5 years
Change in cardiac indices on CMR
2.5 years
Change in cardiac biomarkers
2.5 years
Change in clinical measures
2.5 years
TBR threshold
6 months
Optimise 18F-fluoride PET imaging of ATTR-CM with increased myocardial tissue to background ratio (TBR) uptake values to provide a state-of-the-art imaging modality for use in the other work packages. (n=15, ATTR-CM subjects)
Establish the optimised 18F-fluoride TBR threshold that best differentiates ATTR-CM (n=100) from phenocopies (subjects with light chain amyloidosis, n=20 and subjects with hypertrophic cardiomyopathy, n=20).
In vivo calibration of 18F-fluoride PET as a marker of the myocardial ATTR burden, calibrating optimised TBR values against the current imaging standard cardiac magnetic resonance imaging extracellular volume. (Subjects with ATTR-CM, n=100)
Establish ability of 18F-fluoride PET to track disease progression and treatment response in ATTR-CM at one year follow up. (Subjects with ATTR-CM, n=100)
Positron emission tomography using 18F-fluoride as a tracer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
* Patients with cardiac transthyretin amyloid * Patients with cardiac light chain amyloid * Patients with hypertrophic cardiomyopathy
University Medical Centre Groningen
Groningen, 9713 GZ, Netherlands
Tubben A, Prakken NHJ, Ivashchenko OV, Tingen HSA, Glaudemans AWJM, Noordzij W, Nienhuis HLA, van der Meer P, Slart RHJA. Feasibility of the absolute quantification and left ventricular segmentation of cardiac sympathetic innervation in wild-type transthyretin amyloidosis cardiomyopathy with [123I]-MIBG SPECT/CT: The I-NERVE study. J Nucl Cardiol. 2025 Mar;45:102146. doi: 10.1016/j.nuclcard.2025.102146. Epub 2025 Feb 3.
Marc Dweck, MD PhD
Centre of Cardiovascular Science
Fabien Siepen, MD PhD
Heidelberg University
First Submitted
January 26, 2023
First Posted
March 20, 2023
Study Start
August 25, 2021
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 26, 2026
Record last verified: 2026-06
At the time of publication of the results in a peer-reviewed manuscript, the minimal data set underlying the findings will be made publicly available, either as part of the submission or through a stable, public repository such as EASY (DANS), DataverseNL or Zenodo. The "minimal data set" consists of the data set used to reach the conclusions drawn in the manuscript with related metadata and methods, and any additional data required to replicate the reported study findings in their entirety, including the values behind the means, standard deviations, and other measures reported, the values used to build graphs, and the points extracted from images for analysis. To obtain access to the full data set, a research proposal and analysis plan has to be submitted.
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