Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
105 participants
OBSERVATIONAL
2024-07-30
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ATTR Cardiomyopathy
Patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy)
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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 secondary amyloidosis
18 Years
100 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Mahidol University
OTHER
Responsible Party
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Rungroj Krittayaphong
Professor
Principal Investigators
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Rungroj Krittayaphong, MD, FESC, FACC
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Department of Medicine, Siriraj Hospital, Mahidol University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Sarinya Puwanant, MD
Role: primary
Teerapat Yingchoncharoen, MD
Role: primary
Kanchalaporn Jirataiporn, B.N.S
Role: primary
Hutsaya Prasitdumrong, MD
Role: primary
Arintaya Phrommintikul, MD
Role: primary
Vichai Senthong, MD
Role: primary
Adisai Buakhamsri, MD
Role: primary
Thammarak Songsangjinda, MD
Role: primary
Other Identifiers
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COA-CREC070/2023
Identifier Type: -
Identifier Source: org_study_id
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