Atrial Fibrillation, Cardiomyopathies, Coronary Artery Disease, Heart Failure, Ventricular Arrythmia, Ventricular Tachycardia
Conditions
Keywords
heart failure, registry, cardiomyopathy, atrial fibrillation, ventricular tachycardia, coronary artery disease
Brief summary
The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is a prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). It's objective is to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.
Detailed description
Rationale: Heart failure (HF) represents a heterogeneous range of clinical overlapping cardiomyopathy phenotypes, resulting from multifactorial environmental insults in the presence or absence of a genetic predisposition. A better understanding of (early) cardiomyopathy phenotypes, related cardiovascular diseases, their underlying pathophysiological processes, and their related disease burden is key to pave the way for novel preventive and/or intervention studies. Objective: To optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes. Study design: The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is an investigator-initiated multicentre prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). Study population: All subjects aged ≥16 years that have been referred to the cardiology or genetics department for cardiac symptoms, cardiac screening or cardiogenetic screening are eligible for inclusion. Main study parameters/endpoints: This is a prospective registry from which multiple research questions can be answered. In general, two main approaches will be used: (A) a data-driven (multi-)omics approach which aims to identify clusters of patients to predict clinical outcome, to improve (early) diagnosis, and/or to identify clusters of patients that share underlying pathophysiological processes; (B) a hypothesis-driven approach in which clinical parameters are tested for their (incremental) diagnostic and/or prognostic value.
Interventions
None listed
Sponsors
Zuyderland Medical Centre
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines(3)) or for cardiac/cardiogenetic screening; * Age ≥16 years.
Exclusion criteria
* Unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (sudden) cardiac death or heart transplantation | through study completion, an average of 15 years | Death attributed to a cardiac cause or sudden, or heart transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure hospitalization | through study completion, an average of 15 years | Hospitalization due to cardiac decompensation or prolonged hospitalization due to cardiac decompensation |
| Life-threatening arrhythmias | through study completion, an average of 15 years | justified implantable cardioverter-defibrillator shock, justified anti-tachypacing therapy, cardiac arrest, hemodynamic unstable ventricular tachycardia |
| Quality of life EQ-5D questionnaire | through study completion, an average of 15 years | EQ-5D questionnaire |
| Economic burden | through study completion, an average of 15 years | institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) and iMTA Medical Consumption Questionnaire (iMCQ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Age | through study completion, an average of 15 years | Age based on birth date |
| Sex | through study completion, an average of 15 years | Sex (biological) |
| Body mass index | through study completion, an average of 15 years | BMI |
| Underlying pathogenic | through study completion, an average of 15 years | variants found in cardiac associated genes |
| Medication usage | through study completion, an average of 15 years | Prescribed medication |
Countries
Netherlands
Contacts
Primary ContactJerremy Weerts, MD
Outcome results
None listed