carDIo-ttranSSfOrm nucLEar Imaging Study

Oregon Health and Science University4 enrolled

Overview

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).

This is a multicenter trial of 80 subjects enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) who will undergo baseline and follow up Tc-99m PYP to assess for the change in myocardial uptake of the tracer.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Amyloidosis Transthyretin Amyloid Cardiomyopathy

Interventions

99m-technetium pyrophosphate scintigraphyDIAGNOSTIC_TEST

Imaging test

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * None

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Primary outcome

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.

Time frame: 120-140 weeks

Secondary Outcomes

Secondary outcome

Change in cardiac amyloid activity on Tc-99m PYP SPECT as quantified by the target to background ratio from baseline to end of treatment

Time frame: 120-140 weeks

Secondary outcome

Time frame: 61 weeks

Data from ClinicalTrials.gov

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