The Multicenter Cardiology Monitoring Platform Registry

Coronary Artery Disease Clinical Trial

— mCMPregistry  

Official title:

The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976348
• Other study ID #: NL76585.068.21
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 2051

Study information

• Verified date: January 2023
• Source: Maastricht University Medical Center
• Contact: Jerremy Weerts, MD
• Phone: + 31 43 3871592
• Email: jerremy.weerts[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: December 2051
• Est. primary completion date: December 2051
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Tachycardia

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Zuyderland Medical Centre

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age based on birth date	through study completion, an average of 15 years
Other	Sex	Sex (biological)	through study completion, an average of 15 years
Other	Body mass index	BMI	through study completion, an average of 15 years
Other	Underlying pathogenic	variants found in cardiac associated genes	through study completion, an average of 15 years
Other	Medication usage	Prescribed medication	through study completion, an average of 15 years
Primary	(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	Heart Failure hospitalization	Hospitalization due to cardiac decompensation or prolonged hospitalization due to cardiac decompensation	through study completion, an average of 15 years
Secondary	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
Secondary	Quality of life EQ-5D questionnaire	EQ-5D questionnaire	through study completion, an average of 15 years
Secondary	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

External Links

•   Website with more information on the study