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

Cardiovascular Diseases Clinical Trial

— MyoFit46  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455125
• Other study ID #: 123172
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2022
• Source: University College, London
• Contact: Gabriella Captur, MD PhD MSc MRCP
• Phone: +447809621264
• Email: gabycaptur[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Frailty

Intervention

Diagnostic Test:
• CMR CGI
High resolution ECGI plus advanced CMR

Locations

Country	Name	City	State
United Kingdom	UCL Bloomsbury Centre for Clinical Phenotyping	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMR phenotype - T1	This will be assessed through a 45 minute cardiac MRI scan with perfusion.	Through study completion, an average of 4 years.
Primary	CMR phenotype - T2	This will be assessed through a 45 minute cardiac MRI scan with perfusion.	Through study completion, an average of 4 years.
Primary	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.
Primary	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.