carDIo-ttranSSfOrm nucLEar Imaging Study

Amyloidosis Clinical Trial

— DISSOLvE  

Official title:

carDIo-ttranSSfOrm nucLEar Imaging Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259072
• Other study ID #: 00023310
• Status: Recruiting
• Phase: Phase 3
• Start date: January 19, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2022
• Source: Oregon Health and Science University
• Contact: Ahmad Masri, MD MS
• Phone: 503-494-8582
• Email: masria[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin Amyloid Cardiomyopathy

Intervention

Diagnostic Test:
• 99m-technetium pyrophosphate scintigraphy
Imaging test

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	120-140 weeks
Secondary	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	120-140 weeks
Secondary	Secondary 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 week 61	61 weeks