The Multicenter Cardiology Monitoring Platform Registry (mCMPregistry)

The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 40000

Contacts and Locations

• Study Contact: Name: Jerremy Weerts, MD; Phone Number: + 31 43 3871592; Email: jerremy.weerts@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Recruiting
      • Maastricht UMC+
      • Contact: Jerremy Weerts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Consenting participants; All subjects aged ≥16 years referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines) or for cardiac/cardiogenetic screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(sudden) cardiac death or heart transplantation	Death attributed to a cardiac cause or sudden, or heart transplantation.	through study completion, an average of 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure hospitalization	Hospitalization due to cardiac decompensation or prolonged hospitalization due to cardiac decompensation	through study completion, an average of 15 years
Life-threatening arrhythmias	justified implantable cardioverter-defibrillator shock, justified anti-tachypacing therapy, cardiac arrest, hemodynamic unstable ventricular tachycardia	through study completion, an average of 15 years
Quality of life EQ-5D questionnaire	EQ-5D questionnaire	through study completion, an average of 15 years
Economic burden	institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) and iMTA Medical Consumption Questionnaire (iMCQ)	through study completion, an average of 15 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age based on birth date	through study completion, an average of 15 years
Sex	Sex (biological)	through study completion, an average of 15 years
Body mass index	BMI	through study completion, an average of 15 years
Underlying pathogenic	variants found in cardiac associated genes	through study completion, an average of 15 years
Medication usage	Prescribed medication	through study completion, an average of 15 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Zuyderland Medical Centre
• Investigators: Principal Investigator: Hans-Peter Brunner-La Rocca, Prof., Maastricht University Medical Center

Publications and helpful links

General Publications

• Henkens MTHM, Weerts J, Verdonschot JAJ, Raafs AG, Stroeks S, Sikking MA, Amin H, Mourmans SGJ, Geraeds CBG, Sanders-van Wijk S, Barandiaran Aizpurua A, Uszko-Lencer NHMK, Krapels IPC, Wolffs PFG, Brunner HG, van Leeuwen REW, Verhesen W, Schalla SM, van Stipdonk AWM, Knackstedt C, Li X, Abdul Hamid MA, van Paassen P, Hazebroek MR, Vernooy K, Brunner-La Rocca HP, van Empel VPM, Heymans SRB. Improving diagnosis and risk stratification across the ejection fraction spectrum: the Maastricht Cardiomyopathy registry. ESC Heart Fail. 2022 Apr;9(2):1463-1470. doi: 10.1002/ehf2.13833. Epub 2022 Feb 4.

Helpful Links

• Website with more information on the study

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 1, 2051
• Study Completion (Anticipated): December 1, 2051

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; coronary artery disease; heart failure; registry; cardiomyopathy; ventricular tachycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Failure; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies
• Other Study ID Numbers: NL76585.068.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No