Transthyretin protein cardiac amyloidosis (ATTR-CA, including wild-type ATTRwt and mutant ATTRv)
Conditions
Interventions
Gold Standard:Gold standard: Positive Congo red staining on endomyocardial/extracardiac biopsy, TTR confirmed by mass spectrometry/IHC, or suspected ATTR-CA with positive TTR gene sequencing.
Index test:99Tcm-PYP SPECT(/CT) imaging, including Perugini visual scoring and heart-to-contralateral lung (H/CL) semi-quantitative ratio calculation
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with confirmed red-flag symptoms or a relevant past medical history suggestive of cardiac amyloidosis; 2.Patients with echocardiography or cardiac magnetic resonance imaging showing possible left ventricular hypertrophy or dilation; 3.Patients with a family history of ATTR-CA; 4.Patients with an interval of less than 2 weeks between the 99Tcm-PYP scintigraphy and laboratory examinations; 5.Patients with an interval of less than 1 month between the 99Tcm-PYP scintigraphy and other imaging examinations; 6.Age = 18 years.
Exclusion criteria
Exclusion criteria: 1.Patients with incomplete or missing clinical data. 2.Patients whose 99Tcm-PYP scintigraphy images fail to meet predefined quality control criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under ROC curve of 99Tcm-PYP imaging for ATTR-CA diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perugini visual score;AUC of combined multi-variable diagnostic model;Heart-to-contralateral lung uptake ratio (H/CL); | — |
Countries
China
Contacts
Public ContactLi Huo
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed