NCT05455125

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

4 years

First QC Date

February 16, 2022

Last Update Submit

July 8, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • CMR phenotype - T1

    This will be assessed through a 45 minute cardiac MRI scan with perfusion.

    Through study completion, an average of 4 years.

  • CMR phenotype - T2

    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

    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

    This will be assessed through a 45 minute cardiac MRI scan with perfusion.

    Through study completion, an average of 4 years.

Interventions

CMR CGIDIAGNOSTIC_TEST

High resolution ECGI plus advanced CMR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NSHD cohort

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Bloomsbury Centre for Clinical Phenotyping

London, SW13 0JD, United Kingdom

RECRUITING

Related Publications (2)

  • Topriceanu CC, Webber M, Shiwani H, Chan F, Martin E, Falconer D, Stanley MA, Bennett J, Gonzalez-Martin P, Shah H, De S, Wong A, Pierce I, Davies RH, Lambiase PD, Chaturvedi N, Kellman P, Hardy R, Moon JC, Hughes AD, Captur G. Higher Life-Course Blood Pressure Associates With Reduced Myocardial Perfusion in Older Age: Insights From MyoFit46. Circ Cardiovasc Imaging. 2025 Nov 8:e019105. doi: 10.1161/CIRCIMAGING.125.019105. Online ahead of print.

  • Webber M, Joy G, Bennett J, Chan F, Falconer D, Shiwani H, Davies RH, Krausz G, Tanackovic S, Guger C, Gonzalez P, Martin E, Wong A, Rapala A, Direk K, Kellman P, Pierce I, Rudy Y, Vijayakumar R, Chaturvedi N, Hughes AD, Moon JC, Lambiase PD, Tao X, Koncar V, Orini M, Captur G. Technical development and feasibility of a reusable vest to integrate cardiovascular magnetic resonance with electrocardiographic imaging. J Cardiovasc Magn Reson. 2023 Dec 4;25(1):73. doi: 10.1186/s12968-023-00980-7.

MeSH Terms

Conditions

FrailtyCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriella Captur, MD PhD MSc MRCP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

July 13, 2022

Study Start

July 1, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

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

Locations