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High-Risk Cardiac Device Recipients for Amyloidosis

N/A
Recruiting
Led By Vasvi Singh, MD
Research Sponsored by Midwest Heart & Vascular Specialists
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up retrospective analysis of patient data collected from december 2023 to december 2024
Awards & highlights

Study Summary

This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.

Eligible Conditions
  • ATTR Amyloidosis
  • Amyloidosis
  • AL Amyloidosis
  • Cardiac Amyloidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~december 2023 to december 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed
This trial's timeline: 3 weeks for screening, Varies for treatment, and december 2023 to december 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis
Secondary outcome measures
Development of a predictive screening model for cardiac amyloidosis

Trial Design

1Treatment groups
Experimental Treatment
Group I: High-Risk Cardiac Device RecipientsExperimental Treatment1 Intervention
Participants in this cohort are individuals undergoing clinically indicated cardiac device implantation, such as pacemakers, ICDs, ILRs, or CRT-D/Ps. During the standard implantation procedure, chest wall fat tissue typically excised to create space for the device is collected for histopathological analysis to identify amyloid deposits. This study involves no additional intervention beyond the routine clinical care received by the patients.

Find a Location

Who is running the clinical trial?

Midwest Heart & Vascular SpecialistsLead Sponsor
Vasvi Singh, MDPrincipal InvestigatorMidwest Heart & Vascular Specialists

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Amyloidosis Incidence in High-Risk Cardiac Device Patients
2024. "Amyloidosis Incidence in High-Risk Cardiac Device Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186167.
All > Kansas City
~67 spots leftby Dec 2024
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