AMYLO-STUDY - Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy
Head :
Damy Thibaud, Groupe Hospitalier HENRI MONDORALBERT CHENEVIER
Plante-Bordeneuve Violaine, Groupe Hospitalier HENRI MONDORALBERT CHENEVIER
Slama Michel, Service Cardiologie et Maladies Vasculaires
Plante-Bordeneuve Violaine, Groupe Hospitalier HENRI MONDORALBERT CHENEVIER
Slama Michel, Service Cardiologie et Maladies Vasculaires
Last update : 07/08/2015 | Version : 1 | ID : 8655
| General | |
| Identification | |
| Detailed name | Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy |
| Sign or acronym | AMYLO-STUDY |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Cardiology |
| Health determinants |
Genetic |
| Keywords | heredity, under-diagnosis, mutation, prevalence |
| Scientific investigator(s) (Contact) | |
| Name of the director | Damy |
| Surname | Thibaud |
| Address | 51 Avenue Mal De Lattre De Tassigny 94010 CRETEIL CEDEX |
| Phone | +33 (0)1 49 81 22 53 |
| amylo@sfcardio.fr | |
| Unit | Groupe Hospitalier HENRI MONDORALBERT CHENEVIER |
| Organization | CHU Henri-Mondor |
| Name of the director | Plante-Bordeneuve |
| Surname | Violaine |
| Address | 51 Avenue Mal De Lattre De Tassigny 94010 CRETEIL CEDEX |
| Phone | +33 (0)1 49 81 43 12 |
| violaine.plante@hmn.aphp.fr | |
| Unit | Groupe Hospitalier HENRI MONDORALBERT CHENEVIER |
| Organization | CHU Henri-Mondor |
| Name of the director | Slama |
| Surname | Michel |
| Address | 157, rue de la Porte de Trivaux 92140 Clamart |
| Phone | +33 (0)1 45 37 47 02 |
| michel.slama@abc.ap-hop-paris.fr | |
| Unit | Service Cardiologie et Maladies Vasculaires |
| Organization | Hôpital |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | French Cardiology Society. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société Française de Cardiologie |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | To define the prevalence of TTR amyloidosis in a large population of patients attending the CMH. |
| Inclusion criteria |
- Aged 18 years and over;
- Cardiomyopathy defined by an ultrasound thickness of the left ventricle greater than or equal to13 mm if familial form, or greater than or equal to 15 mm if sporadic form; - Patients with a signed consent authorising the specific blood test for genetic sequencing to look for an abnormal TTR gene. Exclusion criteria: - Significant AS (less than or equal to 1cm2); - Patients with a cardiomyopathy diagnosis (sarcomeric HCM, Fabry disease, etc.) or related already diagnosed. Patients included in the REMY registry (Hypertrophic Cardiomyopathy Registry) may also be included in the amyloid-STUDY. Inclusion criteria are very similar. Some additional data will need to be completed on the page corresponding to the registry. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2012 |
| Date of last collection (YYYY or MM/YYYY) | 04/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | Objective:260. 298 patients enrolled on 30/04/2014. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Weight, height, macroglossia, monoclonal gammopathy, carpal tunnel surgical history, EMG, dysautonomia, gastroparesis. |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | Family and personal history, current or completed treatment. |
| Paraclinical data (detail) | Etiology, MRI, ECG, biopsies. |
| Biological data (detail) | BNP, NT-Pro BNP, troponin, CPK, creatinine, haemoglobin, high-sensitivity CRP, iron level, TSH, serum calcium, serum protein electrophoresis, α-galactosidase A assay, genotyping. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood |
| Details of biobank content | Blood. |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | e-CRF. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
