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| ID | Type | Description | Link |
|---|---|---|---|
| KAHSED-001 | Other Identifier | Kotyora Family Medicine Health Management and Education Association (KAHSED) | |
| pending | Other Identifier | Ordu University Non-Interventional Clinical Research Ethics Committee |
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| Name | Class |
|---|---|
| Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator) | UNKNOWN |
| Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator) | UNKNOWN |
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Cardiac amyloidosis is a progressive infiltrative cardiomyopathy, most commonly related to transthyretin (ATTR) misfolding. Although considered rare, emerging data suggest higher prevalence in specific regions, including the Black Sea area of Turkey. Early recognition improves outcomes. ATTRACT-52 is a prospective, observational, non-interventional screening study in primary care (family medicine centers) across Ordu province. Adults ≥65 years with cardiac or musculoskeletal "red flags" will be screened; those meeting high-suspicion criteria will undergo NT-proBNP/BNP testing at the primary care level to aid risk stratification prior to referral for confirmatory diagnostics.
This study implements a risk-based screening pathway for suspected transthyretin cardiac amyloidosis (ATTR-CM) in primary care. Eligible adults (≥65 years) with relevant cardiac diagnoses (e.g., heart failure, aortic stenosis, cardiomyopathy, AV block, atrial fibrillation) and/or extracardiac red flags (e.g., carpal tunnel syndrome, spinal stenosis, trigger finger) will be reviewed against predefined criteria. When high suspicion is present, NT-proBNP (>600 pg/mL) or BNP (>150 pg/mL) will be obtained in primary care to refine risk prior to referral for confirmatory testing (e.g., bone scintigraphy, CMR) per standard care. Only high-risk patients will be tested; the number of tests will remain limited and appropriate for feasibility. Primary outcomes focus on diagnostic yield and feasibility of this first-line screening model in family medicine settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk-based Screening Cohort | Adults ≥65 years in primary care screened using predefined red flags; high-suspicion cases receive NT-proBNP/BNP testing before referral per standard care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL) | Percentage of high-suspicion cases exceeding the predefined NT-proBNP threshold at baseline. | Baseline (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed cardiac amyloidosis diagnosis rate | Number and proportion of referred participants with confirmed ATTR-CM by standard diagnostics. | Up to 12 months |
| Time from screening to confirmed diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged ≥65 years receiving care at Family Medicine Centers in Ordu province with cardiac and/or extracardiac red flags suggestive of possible ATTR-CM.
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| Name | Affiliation | Role |
|---|---|---|
| Seçkin Dereli, MD, Assoc. Prof. | Ordu University Faculty of Medicine, Department of Cardiology (Turkey) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordu University Faculty of Medicine, Department of Cardiology | Ordu | Ordu | 52200 | Turkey (Türkiye) |
Not planned for this pilot observational screening study.
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| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| C567782 | Amyloidosis, Hereditary, Transthyretin-Related |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
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Interval (days) between initial screening and definitive diagnostic confirmation.
| Up to 12 months |
| Feasibility and physician protocol adherence | Proportion of participating primary care physicians completing all required screening steps. | Up to 12 months |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |