carDIo-ttranSSfOrm nucLEar Imaging Study

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Brief Title

carDIo-ttranSSfOrm nucLEar Imaging Study

Official Title

carDIo-ttranSSfOrm nucLEar Imaging Study

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).
    

Detailed Description

      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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Primary outcome

Secondary Outcome

 Secondary outcome

Condition

Amyloidosis

Intervention

99m-technetium pyrophosphate scintigraphy

Study Arms / Comparison Groups

 Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform
Description:  Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

80

Start Date

January 19, 2022

Completion Date

December 30, 2026

Primary Completion Date

December 30, 2025

Eligibility Criteria

        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
      

Gender

All

Ages

60 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Ahmad Masri, MD MS, 503-494-8582, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05259072

Organization ID

00023310


Responsible Party

Sponsor

Study Sponsor

Oregon Health and Science University

Collaborators

 Ionis Pharmaceuticals, Inc.

Study Sponsor

Ahmad Masri, MD MS, Study Chair, Oregon Health and Science University


Verification Date

February 2022