Transthyretin Amyloid CardiomyopathyALCATTRASSNCT06101108
Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery
An observational study of Transthyretin Amyloid Cardiomyopathy, run by Philippe Debonnaire at 1 site in Belgium.
Trial summary
The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jun 2024to 1 Aug 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients ≥60 years old that undergo lumbar spinal stenosis surgery at the neurosurgery or orthopaedic department with Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
Who may be able to join
- ≥ 60 years old
- Lumbar spinal canal stenosis, undergoing spinal surgery
- Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
Who cannot join
- Prior diagnosis of cardiac amyloidosis
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Sint-Jan Brugge AV
Bruges
Philippe Debonnaire
About this study
Official title: Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery: the Multi-centric ALCATTRASS-study.
The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. This finding may be an early sign of a condition in which other organs (especially the heart) may also be affected by these proteins, called amyloidosis.
Patients who participate in this study, will be followed up for life. During the first routine consultation with the cardiologist, the physician-investigator will collect information, such as demographics (age, weight, height, gender), medical history, medication, symptoms and the results of prescribed examinations. These examinations include microscopic examination of tissue removed during the surgery, blood tests, electrocardiography, echocardiography and a bone scan. These examinations are clinically necessary and appropriate, and patients should undergo them even without participating in the study.
Read the detailed description
Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, severe, yet treatable disease. Lumbar spinal stenosis (SS) in elderly is a red flag for ATTR-CM, often preceding cardiac diagnose by many years. Yet, optimal screening strategies for early ATTR-CM detection at time of SS diagnosis are underused.
Study aim: Multi-centric validation of the diagnostic yield of a standard-of-care prospective screening strategy for early ATTR-CM detection in the elderly, based on ligamentum flavum biopsy assessment at SS surgery.
Design: International, multi-centre, prospective, observational, multi-disciplinary, diagnostic registry.
Methods: All consecutive patients ≥60 years old undergoing standard-of-care ligamentum flavum biopsy as part of symptomatic SS surgery within 12 heart centres are included. The burden of ATTR amyloid deposition (positive Congo-red and pre-albumin staining) is assessed semi-quantitatively by visual Westermark grading. Patients with significant ATTR amyloid burden (grade 3 (≥5-10%) or 4 (>10%) ATTR amyloid on biopsy specimen) undergo standard-of-care work-up to exclude ATTR-CM, conform state-of-the-art clinical practice and ESC recommendations (i.e. baseline cardiac biomarkers, ECG, transthoracic echocardiography, monoclonality assessment and bone-scintigraphy with SPECT; additional CMR and/or endomyocardial biopsy as needed). The diagnostic yield of this biopsy-based strategy will be evaluated.
Conclusion: This trial will validate the diagnostic yield of selective ligamentum flavum biopsy analysis in SS surgery patients as a simple and valuable prospective screening strategy for early ATTR-CM detection.
- Conditions
- Transthyretin Amyloid Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of diagnosis of cardiac amyloidosis
Diagnosis of transthyretin amyloid cardiomyopathy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start24 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid CardiomyopathyStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philippe Debonnaire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe Debonnaire, AZ Sint-Jan AV
- Investigators
- Philippe Debonnaire, MD, PhD, Principal investigator, AZ Sint-Jan Brugge AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101108
- Sponsor's protocol ID
- ALCATTRASS
- Acronym
- ALCATTRASS
- Status last verified
- Aug 2024
- First submitted
- 20 Oct 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery: the Multi-centric ALCATTRASS-study.
- ClinicalTrials.gov ID
- NCT06101108
- Acronym / sponsor ID
- ALCATTRASS / ALCATTRASS
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Philippe DebonnaireUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Oct 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.
The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. This finding may be an early sign of a condition in which other organs (especially the heart) may also be affected by these proteins, called amyloidosis.
Patients who participate in this study, will be followed up for life. During the first routine consultation with the cardiologist, the physician-investigator will collect information, such as demographics (age, weight, height, gender), medical history, medication, symptoms and the results of prescribed examinations. These examinations include microscopic examination of tissue removed during the surgery, blood tests, electrocardiography, echocardiography and a bone scan. These examinations are clinically necessary and appropriate, and patients should undergo them even without participating in the study.
Detailed description
Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, severe, yet treatable disease. Lumbar spinal stenosis (SS) in elderly is a red flag for ATTR-CM, often preceding cardiac diagnose by many years. Yet, optimal screening strategies for early ATTR-CM detection at time of SS diagnosis are underused.
Study aim: Multi-centric validation of the diagnostic yield of a standard-of-care prospective screening strategy for early ATTR-CM detection in the elderly, based on ligamentum flavum biopsy assessment at SS surgery.
Design: International, multi-centre, prospective, observational, multi-disciplinary, diagnostic registry.
Methods: All consecutive patients ≥60 years old undergoing standard-of-care ligamentum flavum biopsy as part of symptomatic SS surgery within 12 heart centres are included. The burden of ATTR amyloid deposition (positive Congo-red and pre-albumin staining) is assessed semi-quantitatively by visual Westermark grading. Patients with significant ATTR amyloid burden (grade 3 (≥5-10%) or 4 (>10%) ATTR amyloid on biopsy specimen) undergo standard-of-care work-up to exclude ATTR-CM, conform state-of-the-art clinical practice and ESC recommendations (i.e. baseline cardiac biomarkers, ECG, transthoracic echocardiography, monoclonality assessment and bone-scintigraphy with SPECT; additional CMR and/or endomyocardial biopsy as needed). The diagnostic yield of this biopsy-based strategy will be evaluated.
Conclusion: This trial will validate the diagnostic yield of selective ligamentum flavum biopsy analysis in SS surgery patients as a simple and valuable prospective screening strategy for early ATTR-CM detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients ≥60 years old that undergo lumbar spinal stenosis surgery at the neurosurgery or orthopaedic department with Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
Key inclusion criteria (3 listed)
- ≥ 60 years old
- Lumbar spinal canal stenosis, undergoing spinal surgery
- Westermark grade 3 or 4 ATTR amyloid burden on ligamentum flavum biopsy
Key exclusion criteria (2 listed)
- Prior diagnosis of cardiac amyloidosis
- Unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of diagnosis of cardiac amyloidosis
Time frame: 1 week
Diagnosis of transthyretin amyloid cardiomyopathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Philippe Debonnaire, MD, PhD principal investigator
AZ Sint-Jan Brugge AV
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 Transthyretin Amyloid Cardiomyopathy, run by Philippe Debonnaire at 1 site in Belgium.
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 2 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 7 Aug 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 Belgium. 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 Emma Christiaen (0032 50 45 32 93, emma.christiaen@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of diagnosis of cardiac amyloidosis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.