Content and purpose of this research
The Netherlands ACM Registry is a national project led by the Netherlands Heart Institute.
Due to the relatively low prevalence of ACM, clinical research on this disease usually consists of small selective cohorts. This often results in insufficient statistical power and limited generalizability of the results found. In addition, results from different studies are difficult to compare due to the lack of uniform definitions. All this limits the translation of research results to the clinic. The purpose of the Netherlands ACM Registry is to overcome these limitations by combining the strength of the various research centres in the Netherlands; by putting together a large national cohort with high quality data, uniform in definitions and collection methods. This way, we hope to be able to facilitate clinical research in development, diagnosis and prognosis of ACM, and in this way further improve patient care in the future.
The Netherlands ACM Registry is a national longitudinal observational cohort of patients with ACM and family members. This study does not fall under the scope of the medical Research Involving Human Subjects Act (niet-WMO) (METC project number 18-126 / C, Utrecht) and is registered with the Dutch Trial Registry (NTR7097).
For more information, click on the questions below, read our design manuscript in The Netherlands Heart Journal, or contact us.
All patients with a proven diagnosis of ACM in which an alternative diagnosis is excluded are eligible for participation. In addition, their family members and other associated mutation carriers can be included.
What does participation mean for my patients (and for me as a therapist)?
This research is observational, so participants do not have to do anything (besides giving us their consent). In addition to demographic and ACM-related DNA data, clinical data is collected and stored, including: (1) complaints and symptoms; (2) use of medication and treatment, (3) diagnostic data such as results from the ECG, Holter, exercise test, ultrasound, MRI and angiography, (4) external factors such as pregnancy, intoxication and sport, (5) outcomes such as arrhythmia, heart failure and (heart-)death.
What happens to this patient data?
This data is stored securely and anonymously in a unique study code. Only researchers from the primary academic centre where the patient is (or have been) treated will have access to these data and only with the permission of a locally appointed coordinator. In addition, the researchers at the Netherlands Heart Institute monitor the validity and quality of the data. The use of data for research in one of the participating centres is only done after permission from the local coordinator. For joint research in the entire database, permission from the NHI coordinators is required.
How can I register my patients for participation?
If you work in one of the participating academic centres, you should contact the local coordinator at the cardiology or clinical genetics department. If you are not aware who this is, you can contact us.
If you work at another hospital or healthcare institution, please contact us or refer your patients who meet the above inclusion criteria to our website for more information about participation. If desired, we can send you the patient information letter so that you are aware of the content as well.