Thailand ATTR-CM Registry
Recruiting · NCT06338696 · Observational (researchers observe without assigning treatment) · Lead sponsor: Mahidol University
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
8 locations listed.
- Faculty of Medicine at Chulalongkorn University - Bangkok, Thailand
- Faculty of Medicine Ramathibodi hospital, Mahidol University - Bangkok, Thailand
- Faculty of Medicine Siriraj Hospital, Mahidol University - Bangkok, Thailand
- Phramongkutklao Hospital - Bangkok, Thailand
- Faculty of Medicine Chiang Mai University - Chiang Mai, Thailand
- Queen Sirikit Heart Center of The Northeast - Khon Kaen, Thailand
- Faculty of Medicine, Thammasat University - Pathum Thani, Thailand
- Prince of Songkla University - Songkhla, Thailand