Diagnosing cardiac amyloidosis in high-risk patients with cardiac devices
Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
Midwest Heart & Vascular Specialists · NCT06186167
This study is testing if analyzing fat tissue from patients getting heart devices can help doctors better diagnose cardiac amyloidosis in those at high risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Midwest Heart & Vascular Specialists (other) |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT06186167 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to improve the diagnosis of cardiac amyloidosis in patients undergoing cardiac device implantation. By analyzing chest wall fat tissue, which is typically discarded, the study seeks to determine the diagnostic yield of these biopsies for amyloidosis. It will also develop a predictive screening model based on clinical, lab, and imaging data. The study is set to enroll 100 patients from December 2023 to December 2024, focusing on enhancing diagnostic efficiency for this serious condition.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and older who are scheduled for cardiac implantable electronic device implantation and show clinical signs suggestive of cardiac amyloidosis.
Not a fit: Patients under 40 years of age or those already diagnosed with cardiac amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and improved treatment strategies for patients at high risk of cardiac amyloidosis.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are 40 years of age or older * Patients who are able and willing to provide informed consent * Patients who are scheduled for CIED implantation within the study period and with clinical lab and imaging features suggestive of cardiac amyloidosis Exclusion Criteria: * Individuals below the age of 40. * Persons who are unable to consent or who do not consent to participate. * Patients who have already been diagnosed with cardiac amyloidosis prior to the study
Where this trial is running
Overland Park, Kansas
- Midwest Heart & Vascular Specialists — Overland Park, Kansas, United States (RECRUITING)
Study contacts
- Principal investigator: Vasvi Singh, MD — Midwest Heart & Vascular Specialists
- Study coordinator: Vasvi Singh, MD
- Email: vasvi.singh@hcahealthcare.com
- Phone: (913) 253-3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyloid, Cardiac Amyloidosis, Amyloidosis Cardiac, Systemic Amyloidosis, AL Amyloidosis, Infiltrative Cardiomyopathy, Amyloid, ATTR Amyloidosis Wild Type, Cardiac Devices