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This multicenter, prospective, single-arm, interventional study will enroll about 4,000 adult patients at high risk of ATTR amyloidosis from around 50 sites in China. Eligible patients are aged ≥60 years and have documented symptomatic heart failure with left ventricular ejection fraction ≥40% and LVH. Exclusion criteria include known etiologies of myocardial diseases, anomalies of serum free light chain or serum immunofixation electrophoresis, acute myocardial infarction within 6 months before screening, and inability to undergo 99mTc-PYP. Patients will undergo a 14-week diagnostic process.
The study intervention involves knowledge training, operation training and post-training verification among investigators. Knowledge training for CV department investigators will cover disease-specific knowledge, standard diagnostic pathways, and genetics; training for investigators in echocardiology (ECHO) and nuclear medicine departments will focus on disease knowledge, standardized operating procedures (SOPs), and imaging parameter reporting. Operation training includes hands-on training in SOPs and image interpretation for ECHO and nuclear medicine investigators. Post-training verification will assess site-level compliance. Extra training will be arranged if quality audit is off target.
The primary endpoint is the proportion of patients diagnosed with ATTR amyloidosis in high-risk populations. Secondary endpoints include the proportion of patients with ATTRwt amyloidosis, concordance between local investigators and central reviewers in ECHO and 99mTc-PYP readings, and genotype distribution. All analyses will be descriptive with no pre-planned hypotheses. Risk factors associated with 99mTc-PYP-diagnosed ATTR amyloidosis will be analyzed via logistic regression models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one arm without control group | Other | This is a multi-center, prospective, single-arm interventional study to evaluate the impact of the implementation of standardized ATTR early identification and diagnosis in ATTR high risk population. This study will enroll approximately 4,000 adult Chinese patients at high risk for ATTR from around 50 sites in China. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implementation of standard early identification and diagnosis of ATTR | Behavioral | The intervention methods include standardized ATTR early identification and diagnosis protocol, as well as quality audit. The standardized ATTR early identification and diagnosis protocol involves knowledge training, operation training and verification. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients diagnosed with ATTR in high-risk population. | Week 14 |
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Inclusion Criteria:
Exclusion Criteria:
1)Previously documented hypersensitivity reaction to 99mTc; 2)Severe renal insufficiency (eGFR <30 mL/min/1.73m²); 3)Severe myelosuppression (leukocytes <3.5×10⁹/L or platelets <80×10⁹/L). 6.Other medical or psychiatric condition including recent (within the past year) active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Beijing | 100029 | China | ||
| Research Site |
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| Not yet recruiting |
| Beijing |
| 100034 |
| China |
| Research Site | Not yet recruiting | Beijing | 100037 | China |
| Research Site | Not yet recruiting | Beijing | 100142 | China |
| Research Site | Not yet recruiting | Beijing | 100191 | China |
| Research Site | Not yet recruiting | Changlexi | 710032 | China |
| Research Site | Not yet recruiting | Changsha | 410000 | China |
| Research Site | Not yet recruiting | Changsha | 410008 | China |
| Research Site | Not yet recruiting | Changsha | 410011 | China |
| Research Site | Not yet recruiting | Chengdu | 610041 | China |
| Research Site | Not yet recruiting | Chengdu | 610072 | China |
| Research Site | Not yet recruiting | Chongqing | 400016 | China |
| Research Site | Not yet recruiting | Chongqing | 400030 | China |
| Research Site | Not yet recruiting | Dalian | 116011 | China |
| Research Site | Not yet recruiting | Fuzhou | 350001 | China |
| Research Site | Not yet recruiting | Fuzhou | 350005 | China |
| Research Site | Not yet recruiting | Guangdong Province | 510060 | China |
| Research Site | Not yet recruiting | Guangzhou | 510100 | China |
| Research Site | Not yet recruiting | Guangzhou | 510515 | China |
| Research Site | Not yet recruiting | Guiyang | 550044 | China |
| Research Site | Not yet recruiting | Hangzhou | 310009 | China |
| Research Site | Not yet recruiting | Harbin | 150001 | China |
| Research Site | Not yet recruiting | Hefei | 230001 | China |
| Research Site | Not yet recruiting | Hefei | 230022 | China |
| Research Site | Not yet recruiting | Jinan | 250012 | China |
| Research Site | Not yet recruiting | Jinan | 250021 | China |
| Research Site | Not yet recruiting | Nanchang | 330006 | China |
| Research Site | Not yet recruiting | Nanjing | 210006 | China |
| Research Site | Not yet recruiting | Nanjing | 210029 | China |
| Research Site | Not yet recruiting | Nanning | 530000 | China |
| Research Site | Not yet recruiting | Qingdao | 266003 | China |
| Research Site | Recruiting | Shanghai | 200032 | China |
| Research Site | Not yet recruiting | Shanghai | 200040 | China |
| Research Site | Not yet recruiting | Shanghai | 200080 | China |
| Research Site | Not yet recruiting | Shanghai | China |
| Research Site | Not yet recruiting | Shenyang | 110001 | China |
| Research Site | Not yet recruiting | Shijiazhuang | 050001 | China |
| Research Site | Not yet recruiting | Shijiazhuang | 50051 | China |
| Research Site | Not yet recruiting | Suzhou | 215006 | China |
| Research Site | Not yet recruiting | Taiyuan | 030001 | China |
| Research Site | Not yet recruiting | Wenzhou | 325000 | China |
| Research Site | Not yet recruiting | Wuhan | 430030 | China |
| Research Site | Not yet recruiting | Wuhan | 430060 | China |
| Research Site | Not yet recruiting | Wuhan | 430071 | China |
| Research Site | Not yet recruiting | Wuhan | CN-430022 | China |
| Research Site | Not yet recruiting | Xi'an | 710061 | China |
| Research Site | Not yet recruiting | Xiamen | 361003 | China |
| Research Site | Not yet recruiting | Zhengzhou | 450000 | China |