The Multicenter Cardiology Monitoring Platform Registry

Recruiting

• Conditions: Heart Failure; Ventricular Arrythmia; Coronary Artery Disease; Atrial Fibrillation; Ventricular Tachycardia; Cardiomyopathies

• Registration Number: NCT04976348
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2021-06-22
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2051-12
• Study Completion: 2051-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands