Thailand ATTR-CM Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Thailand Transthyretin Amyloid Cardiomyopathy Registry
Overview
The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Rate of death [Time frame: 3 years]
- Rate of heart failure hospitalization [Time frame: 3 years]
Secondary outcome measures (1)
- Transthyretin (ATTR) amyloidosis medication [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Age > 18 years.
- All patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy) who have either symptomatic or asymptomatic must have evidence of cardiac involvement by echocardiogram as defined by left ventricle wall thickness of ≥ 12 mm and with at least one of the following criteria:
- Positive scintigraphy by 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\] or 99mTC-PYP \[Pyrophosphate\] or 99mTC-HMDP \[hydroxymethylene diphosphate\] with Perugini grade ≥ 2 and/or H/CL (heart to contralateral lung) ratio > 1.5
- Positive scintigraphy by 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\] or 99mTC-PYP \[Pyrophosphate\] or 99mTC-HMDP \[hydroxymethylene diphosphate\] with Perugini grade 1 and positive cardiac biopsy tissue confirmed which Congo red stain ≥ 4 sites
- Positive scintigraphy by 99mTC-DPD \[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\] or 99mTC-PYP \[Pyrophosphate\] or 99mTC-HMDP \[hydroxymethylene diphosphate\] with Perugini grade 1 with positive non-cardiac biopsy tissue confirmed by Congo red stain
- Abnormalities on CMR (Cardiac MRI) \[Subendocardium LGE (late gadolinium enhancement) and/or elevated native T1 value and/or increased extracellular volume (ECV > 0.4)\] with positive non-cardiac and/or cardiac tissue biopsy confirmed by Congo red stain
Exclusion criteria
- Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
- Diagnosed with secondary amyloidosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Thailand · 8 centers
- Faculty of Medicine at Chulalongkorn University — Bangkok
- Faculty of Medicine Ramathibodi hospital, Mahidol University — Bangkok
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok
- Phramongkutklao Hospital — Bangkok
- Faculty of Medicine Chiang Mai University — Chiang Mai
- Queen Sirikit Heart Center of The Northeast — Khon Kaen
- Faculty of Medicine, Thammasat University — Pathum Thani
- Prince of Songkla University — Songkhla
Identifiers
NCT: NCT06338696 · COA-CREC070/2023