The Multicenter Cardiology Monitoring Platform Registry (mCMPregistry)

November 19, 2024 updated by: Maastricht University Medical Center

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

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 (Estimated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: through study completion, an average of 15 years
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
Time Frame: through study completion, an average of 15 years
Hospitalization due to cardiac decompensation or prolonged hospitalization due to cardiac decompensation
through study completion, an average of 15 years
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
through study completion, an average of 15 years
Quality of life EQ-5D questionnaire
Time Frame: through study completion, an average of 15 years
EQ-5D questionnaire
through study completion, an average of 15 years
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)
through study completion, an average of 15 years

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 1, 2051

Study Completion (Estimated)

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 (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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