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NCT Number: NCT04976348

The Multicenter Cardiology Monitoring Platform 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. (sudden) cardiac death or heart transplantation

    Time frame: through study completion, an average of 15 years

    Death attributed to a cardiac cause or sudden, or heart transplantation.

Secondary outcomes

  1. Heart Failure hospitalization

    Time frame: through study completion, an average of 15 years

    Hospitalization due to cardiac decompensation or prolonged hospitalization due to cardiac decompensation

  2. Life-threatening arrhythmias

    Time frame: through study completion, an average of 15 years

    justified implantable cardioverter-defibrillator shock, justified anti-tachypacing therapy, cardiac arrest, hemodynamic unstable ventricular tachycardia

  3. Quality of life EQ-5D questionnaire

    Time frame: through study completion, an average of 15 years

    EQ-5D questionnaire

  4. Economic burden

    Time frame: 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 outcomes

  1. Age

    Time frame: through study completion, an average of 15 years

    Age based on birth date

  2. Sex

    Time frame: through study completion, an average of 15 years

    Sex (biological)

  3. Body mass index

    Time frame: through study completion, an average of 15 years

    BMI

  4. Underlying pathogenic

    Time frame: through study completion, an average of 15 years

    variants found in cardiac associated genes

  5. Medication usage

    Time frame: through study completion, an average of 15 years

    Prescribed medication

Study contacts

Contact information is provided by the study sponsor or research team.

Jerremy Weerts, MD

CONTACT

[email protected]

+ 31 43 3871592

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Zuyderland Medical Centre

Registry information

Official study title

The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)

Acronym: mCMPregistry

Important dates

Study start
2021
Primary completion
2051
Study completion
2051
First posted
Jul 26, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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