AmyloidNCT06186167
Amyloidosis Incidence in High-Risk Cardiac Device Patients
An observational study of Amyloid and Cardiac Amyloidosis, run by Midwest Heart & Vascular Specialists at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Amyloid, Cardiac Amyloidosis, Amyloidosis Cardiac
- What is being tested?
- Chest Wall Fat Tissue Collection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk patients undergoing cardiac device implantation who meet the study's inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Midwest Heart & Vascular Specialists
Overland Park, Kansas, 66211
Elizabeth Fulks, MS, 913-253-3000, elizabeth.fulks@hcahealthcare.com
About this study
Official title: Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
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.
Read the detailed description
The study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers, ICDs, and CRT-D/Ps. Standard surgical procedures are adhered to, ensuring minimal additional risk to patients. The collected tissue samples are analyzed by the HCA pathology laboratory to detect amyloid deposits, thereby potentially identifying amyloidosis in a non-invasive manner. In addition to the primary endpoint of histopathological diagnosis, the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis. Strict measures are in place to protect patient confidentiality and data security. By potentially improving diagnostic efficiency, this research could contribute to earlier detection and treatment strategies, thus improving patient outcomes for those at high risk of this life-threatening condition.
- Conditions
- Amyloid, Cardiac Amyloidosis, Amyloidosis Cardiac, Systemic Amyloidosis, AL Amyloidosis, Infiltrative Cardiomyopathy, Amyloid
- Being tested
- Chest Wall Fat Tissue Collection
- Keywords
- Cardiac Devices, Chest Wall Fat Pad Biopsy, Cardiac Implantable Electronic Devices
- Medical subject headings
- Alzheimer Disease, Amyloid Neuropathies, Familial, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Wall Fat Tissue CollectionProcedure or surgery
As part of routine cardiac device implantation, chest wall fat tissue is collected for histopathological analysis. This tissue, which is typically discarded, will be used to identify amyloid deposits in high-risk cardiac patients. No additional surgical intervention is performed beyond the standard procedure for device implantation.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk Cardiac Device Recipients | 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. Receives: Procedure: Chest Wall Fat Tissue Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis
The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation
Measured: December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed
Secondary outcomes (1)
Development of a predictive screening model for cardiac amyloidosis
Retrospective development and validation of a predictive model using pre-procedural clinical, lab, and imaging data to identify patients at high risk for cardiac amyloidosis
Measured: Retrospective analysis of patient data collected from December 2023 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start29 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmyloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Heart & Vascular Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vasvi Singh, MD, Principal investigator, Midwest Heart & Vascular Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186167
- Sponsor's protocol ID
- MWHV-AMYLO-BIOP-001
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At present, the specifics of a data-sharing plan for individual participant data (IPD) from this study are under consideration. The study team intends to protect patient confidentiality and data integrity and will comply with all relevant regulations and guidelines for data sharing. Once a plan has been established, details about the nature of the data to be shared, the conditions for access, and the timing for data release will be provided.
Publications
Takano R, Ueda N, Okada A, Matsumoto M, Ikeda Y, Hatakeyama K, Izumi C, Kusano K. Fat biopsy from a pocket of cardiac implantable electronic device: An alternative diagnostic option for cardiac amyloidosis. HeartRhythm Case Rep. 2022 May 18;8(8):554-557. doi: 10.1016/j.hrcr.2022.05.008. eCollection 2022 Aug. No abstract available.
PubMed 35996711
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation
- ClinicalTrials.gov ID
- NCT06186167
- Acronym / sponsor ID
- MWHV-AMYLO-BIOP-001
- Conditions
- Amyloid, Cardiac Amyloidosis, Amyloidosis Cardiac, Systemic Amyloidosis, AL Amyloidosis, Infiltrative Cardiomyopathy, Amyloid
- Keywords
- Cardiac Devices, Chest Wall Fat Pad Biopsy, Cardiac Implantable Electronic Devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Midwest Heart & Vascular SpecialistsUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers, ICDs, and CRT-D/Ps. Standard surgical procedures are adhered to, ensuring minimal additional risk to patients. The collected tissue samples are analyzed by the HCA pathology laboratory to detect amyloid deposits, thereby potentially identifying amyloidosis in a non-invasive manner. In addition to the primary endpoint of histopathological diagnosis, the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis. Strict measures are in place to protect patient confidentiality and data security. By potentially improving diagnostic efficiency, this research could contribute to earlier detection and treatment strategies, thus improving patient outcomes for those at high risk of this life-threatening condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Cardiac Device Recipients | – | Procedure: Chest Wall Fat Tissue CollectionParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk patients undergoing cardiac device implantation who meet the study's inclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Wall Fat Tissue CollectionAs part of routine cardiac device implantation, chest wall fat tissue is collected for histopathological analysis. This tissue, which is typically discarded, will be used to identify amyloid deposits in high-risk cardiac patients. No additional surgical intervention is performed beyond the standard procedure for device implantation. | Procedure or surgery | High-Risk Cardiac Device Recipients |
Primary outcome
Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis
Time frame: December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed
The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation
1 secondary outcome
Development of a predictive screening model for cardiac amyloidosis
Time frame: Retrospective analysis of patient data collected from December 2023 to December 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 35996711Takano R, Ueda N, Okada A, Matsumoto M, Ikeda Y, Hatakeyama K, Izumi C, Kusano K. Fat biopsy from a pocket of cardiac implantable electronic device: An alternative diagnostic option for cardiac amyloidosis. HeartRhythm Case Rep. 2022 May 18;8(8):554-557. doi: 10.1016/j.hrcr.2022.05.008. eCollection 2022 Aug. No abstract available.
- Individual participant dataSharing planned: Undecided. At present, the specifics of a data-sharing plan for individual participant data (IPD) from this study are under consideration. The study team intends to protect patient confidentiality and data integrity and will comply with all relevant regulations and guidelines for data sharing. Once a plan has been established, details about the nature of the data to be shared, the conditions for access, and the timing for data release will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasvi Singh, MD principal investigator
Midwest Heart & Vascular Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloid and Cardiac Amyloidosis, run by Midwest Heart & Vascular Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasvi Singh, MD ((913) 253-3000, vasvi.singh@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of chest wall fat pad biopsy for cardiac amyloidosis (time frame: December 2023 to December 2024, corresponding to the study duration during which patients will be enrolled and outcomes will be assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06186167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.