免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Study Description
Brief Summary:
Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction.
Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.
This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amyloidosis Cardiac Carpal Tunnel Syndrome | Diagnostic Test: DPD Scintigraphy | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome |
| Actual Study Start Date : | June 17, 2019 |
| Estimated Primary Completion Date : | November 1, 2020 |
| Estimated Study Completion Date : | February 1, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Suspicion of cardiac amyloidosis
Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.
|
Diagnostic Test: DPD Scintigraphy
Confirms/Refutes diagnosis of cardiac amyloidosis.
|
Outcome Measures
Primary Outcome Measures :
- Prevalence of cardiac amyloidosis. [ Time Frame: Through study completion, an average of 2 years. ]The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.
Eligibility Criteria
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the Region of Central Denmark (Region Midtjylland) the last five years.
- Informed written and verbal consent
Exclusion Criteria:
-
Operation by different indication such as
- Fracture
- Ganglion
- Tumors
- Osteophytes
- Rheumatoid Arthritis
- Persistent medial artery
- Metabolic causes
- Alcoholism
- Hyperthyroidism
-
Myxedema
- Hereditary Cardiac Amyloidosis
- Known WT ATTR
- AL Amyloidosis
- Myelomatosis
- MGUS and Morbus Waldenström
Contacts and Locations
Contacts
| Contact: Steen Hvitfeldt Poulsen | +4530922309 | steepoul@rm.dk | |
| Contact: Bertil Ladefoged | +4540927245 | 201307379@post.au.dk |
Locations
| Denmark | |
| Department of Heart Disease | Recruiting |
| Aarhus, Denmark, 8200 | |
| Contact: Steen Hvitfeldt Poulsen, Professor +4530922309 steepoul@rm.dk | |
Sponsors and Collaborators
Aarhus University Hospital Skejby
Regional Hospital Holstebro
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 17, 2019 | ||||||||
| First Posted Date ICMJE | June 24, 2019 | ||||||||
| Last Update Posted Date | February 19, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 17, 2019 | ||||||||
| Estimated Primary Completion Date | November 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Prevalence of cardiac amyloidosis. [ Time Frame: Through study completion, an average of 2 years. ] The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome.
|
||||||||
| Original Primary Outcome Measures ICMJE |
Diagnosis of cardiac amyloidosis. [ Time Frame: Through study completion, an average of 1 year. ] Patients under suspicion of cardiac amyloidosis will have a 99mTc-DPD scintigraphy performed to confirm/refute the diagnosis. A Perugini score of 2-3 is considered diagnostic.
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome | ||||||||
| Official Title ICMJE | Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome | ||||||||
| Brief Summary |
Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction. Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand. This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Diagnostic Test: DPD Scintigraphy
Confirms/Refutes diagnosis of cardiac amyloidosis.
|
||||||||
| Study Arms ICMJE | Suspicion of cardiac amyloidosis
Patients who display signs of cardiac amyloidosis will be referred for further diagnosis.
Intervention: Diagnostic Test: DPD Scintigraphy
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | February 1, 2021 | ||||||||
| Estimated Primary Completion Date | November 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Denmark | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03996382 | ||||||||
| Other Study ID Numbers ICMJE | 1-10-72-330-18 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby | ||||||||
| Study Sponsor ICMJE | Aarhus University Hospital Skejby | ||||||||
| Collaborators ICMJE | Regional Hospital Holstebro | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Aarhus University Hospital Skejby | ||||||||
| Verification Date | February 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
