carDIo-ttranSSfOrm nucLEar Imaging Study

NCT ID: NCT05259072

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-19

Study Completion Date

2023-12-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Amyloidosis Transthyretin Amyloid Cardiomyopathy

Study Groups

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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

99m-technetium pyrophosphate scintigraphy

Intervention Type DIAGNOSTIC_TEST

Imaging test

Interventions

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99m-technetium pyrophosphate scintigraphy

Imaging test

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Tc-99m PYP

Eligibility Criteria

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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.

Exclusion Criteria

* Patient willing to consent for the study and undergo the study procedures.


* None
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ionis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Masri

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Masri, MD MS

Role: STUDY_CHAIR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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00023310

Identifier Type: -

Identifier Source: org_study_id

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