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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002835-27 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.
Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ION-682884-CS2 Scintigraphy Subset | Participants randomized in ION-682884-CS2 (NCT04136171) study to receive either eplontersen or placebo with baseline scintigraphy scan with planar and single-photon emission computerized tomography (SPECT) or SPECT with computed tomography (SPECT/CT) images will undergo an optional scintigraphy scan at Weeks 25 or 37, Week 97, and an additional scan at Week 140. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scintigraphy scan | Diagnostic Test | Scans will be performed as specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140 | The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate [PYP], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative. | Baseline up to Week 140 |
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Inclusion Criteria:
Exclusion criteria:
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Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and who signed informed consent for the Scintigraphy sub-study will participate in this sub-study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States | ||
| Duke University Medical Center |
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| Label | URL |
|---|---|
| CARDIO-TTRansform Website | View source |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000076665 | Ventilation-Perfusion Scan |
| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Durham |
| North Carolina |
| 27710 |
| United States |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Hospital Universitario Puerta de Hierro | Majadahonda | 28222 | Spain |
| D002318 | Cardiovascular Diseases |
| D003947 |
| Diagnostic Techniques, Radioisotope |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |