An observational study in ATTR Amyloidosis, Cardiopathy and Carpal Tunnel Syndrome, sponsored by Institut Mutualiste Montsouris. Recruiting at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Institut Mutualiste Montsouris · Observational
Among 124 studies in Heart Diseases with a site in France — 27 open to participants now, 35 under way, 5 of them phase 3. Heart Diseases · France.
Among the 124 studies in Heart Diseases with a site in France, this one is the 32nd largest by planned enrollment of the 46 observational ones, is one of 7 that started in 2024, is one of 46 observational ones, reaches primary completion later than 4 of the 34 other live ones, and was the 110th registered.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
This study's planned enrollment of 150 is below the median of 350 across 592 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →27 of the 124 studies in Heart Diseases with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 180 Heart Diseases studies recruiting now, 128 (71%) set no upper age limit and 21 (12%) stop at 75 or younger; 32 take children under 18; 42 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →124 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 7 started in 2024.
Median enrollment 240 across the 77 interventional studies, 375 across the 46 observational. Of the 76 that completed or were terminated, 23 (30%) have results posted.
53 of 124 have an industry lead sponsor. The 10 most frequent:
Institut Mutualiste Montsouris is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Institut Mutualiste Montsouris has 1 study filed under Heart Diseases — fewer than ten, so there is no comparison to draw.
10 of the studies in Heart Diseases with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05476991Phase 3Assistance Publique - Hôpitaux de ParisEvaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis | 2027-09-01 |
| NCT06438159ElsanImpact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation. | 2026-11-12 |
| NCT03142152Cardiac Dimensions, Inc.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR | 2026-12-31 |
| NCT06420960L'hôpital Nord-Ouest - Villefranche Villefranche sur SaôneDiagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG | 2027-01-18 |
| NCT07888218Central Hospital, Nancy, FranceReplacing Spatial Filtering With Deep-learning Noise Reduction | 2027-01-23 |
Among the 124 studies in Heart Diseases with a site in France, from their registry updates:
The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:
What are the preoperative predictors of ATTR deposits? Participants will
Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries
Patients meeting the inclusion criteria in a single orthopaedic surgery center located in Paris, France
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
undergoing surgery for
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
frequency of ATTR amyloidosis
presence of ATTR amyloidosis in surgical samples by immunohistochemistry performed when samples countain amyloi by Congo red.ATTR will be semiquantitalively assessed using a published scale.
Time frame: 18 months
presence of ATTR cardiopathy
Diagnosis by multimodal imaging(bone scintigraphy, cardiac US scan, MRI)
Time frame: 20 months
proportion of wild type and hereditary ATTR
hereditary: patients exibit a mutation of the TTR gene, wild type: no mutation. TTR genotyping will determine if the gene is muted (hereditary ATTR) or not (wild type).
Time frame: 20 months
Description of preoperative predictors of ATTR
features more frequent in patients diagnosed with ATTR versus not: - demographic and clinical characteristics, will be collected before surgery and compared in ATTR positive and ATTR negative patients.
Time frame: 18 months
Description of preoperative predictors of ATTR
features more frequent in patients diagnosed with ATTR versus not: - imaging characteristics (USscans of rotator cuff, hip capsula and carpal tunel) will be collected before surgery and compared in ATTR positive and ATTR negative patients.
Time frame: 18 months
preoperative predictors of ATTR
biochemical features more frequent in patients diagnosed with ATTR versus not: * troponine (g/L) * BNP (ng/L) * proteuniria (ng/L) will be collected before surgery and compared in ATTR positive and ATTR negative patients.
Time frame: 18 months
Started Feb 2024 (actual). Primary completion is estimated for Apr 2025, 14 months after the start.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Institut Mutualiste Montsouris