MultiMorbidity Life-Course Approach To Myocardial Health -A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD) (MyoFit46)

July 8, 2022 updated by: University College, London

A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)

Background The life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. The Medical Research Council National Survey of Health and Development (NSHD) is the world's longest running continued surveillance birth cohort providing a unique opportunity to understand life course determinants of myocardial dysfunction as part of MyoFit46-the cardiac sub-study of the NSHD.

Methods and expected results The investigators aim to recruit 550 NSHD participants of approximately 75 years+ to undertake high-density surface electrocardiographic imaging (ECGI) and stress perfusion cardiovascular magnetic resonance (CMR). Through comprehensive myocardial tissue characterization and 4-dimensional flow the investigators hope to better understand the burden of clinical and subclinical cardiovascular disease. Supercomputers will be used to combine the multi-scale ECGI and CMR datasets per participant. Rarely available, prospectively collected whole-of-life data on exposures, traditional risk factors and multimorbidity will be studied to identify risk trajectories, critical change periods, mediators and cumulative impacts on the myocardium.

Conclusion By combining well curated, prospectively acquired longitudinal data of the NSHD with novel CMR-ECGI data and sharing these results and associated pipelines with the CMR community, MyoFit46 seeks to transform our understanding of how early, mid and later-life risk factor trajectories interact to determine the state of cardiovascular health in older age.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

550

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NSHD cohort

Description

Inclusion Criteria:

  • NSHD study member.
  • Who is still alive and agreed to take part in the study.

Exclusion Criteria:

  • Pacemaker.
  • Implantable cardio defibrillator.
  • Atrial fibrillation.
  • Complete heart block.
  • Severe asthma.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMR phenotype - T1
Time Frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Through study completion, an average of 4 years.
CMR phenotype - T2
Time Frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Through study completion, an average of 4 years.
CMR phenotype - Myocardial blood flow
Time Frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Through study completion, an average of 4 years.
CMR phenotype - Aortic blood flow
Time Frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Through study completion, an average of 4 years.

Collaborators and Investigators

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

Sponsor

University College, London

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, 2020

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Non-identifiable data sharing to external collaborators. Additional data sharing available within UCL TRE.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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