RecruitingNCT06338696

Thailand ATTR-CM Registry

Thailand Transthyretin Amyloid Cardiomyopathy Registry


Sponsor

Mahidol University

Enrollment

105 participants

Start Date

Jul 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria6

  • 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 Criteria2

  • Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)
  • Diagnosed with secondary amyloidosis

Interventions

OTHERNo intervention

No intervention


Locations(8)

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

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NCT06338696


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