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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05259072
Registration number
NCT05259072
Ethics application status
Date submitted
17/02/2022
Date registered
28/02/2022
Date last updated
29/01/2025
Titles & IDs
Public title
carDIo-ttranSSfOrm nucLEar Imaging Study
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Scientific title
carDIo-ttranSSfOrm nucLEar Imaging Study
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Secondary ID [1]
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00023310
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Universal Trial Number (UTN)
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Trial acronym
DISSOLvE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Amyloidosis
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0
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Transthyretin Amyloid Cardiomyopathy
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0
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Condition category
Condition code
Metabolic and Endocrine
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0
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Metabolic disorders
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Metabolic and Endocrine
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0
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0
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Other metabolic disorders
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Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - 99m-technetium pyrophosphate scintigraphy
Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform - Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial
Diagnosis / Prognosis: 99m-technetium pyrophosphate scintigraphy
Imaging test
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary outcome
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Assessment method [1]
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Percentage of patients in both treatment groups with an improvement in the semi-quantitative visual grade by at least 1 grade from baseline and an improvement in the heart/contralateral ratio by at least 20% from baseline to end of treatment.
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Timepoint [1]
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120-140 weeks
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Secondary outcome [1]
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Secondary outcome
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Assessment method [1]
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Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment
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Timepoint [1]
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120-140 weeks
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Secondary outcome [2]
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Secondary outcome
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Assessment method [2]
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Percentage of patients in both treatment groups with an improvement in the semi-quantitative visual grade by at least 1 grade from baseline and an improvement in the heart/contralateral ratio by at least 20% from baseline to week 61
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Timepoint [2]
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61 weeks
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Eligibility
Key inclusion criteria
* Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
* Patients have to meet the inclusion and exclusion criteria of CARDIO-TTRansform trial to be enrolled.
* Patient willing to consent for the study and undergo the study procedures.
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Minimum age
60
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* None
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2023
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Sample size
Target
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Oregon
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Funding & Sponsors
Primary sponsor type
Other
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Name
Oregon Health and Science University
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Ionis Pharmaceuticals, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).
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Trial website
https://clinicaltrials.gov/study/NCT05259072
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Ahmad Masri, MD MS
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Address
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Oregon Health and Science University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ahmad Masri, MD MS
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Address
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Country
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Phone
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503-494-8582
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05259072
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