Deriving Cardiac Reference Ranges at 3.0Tesla in Healthy Volunteers

NCT05241184 | Unknown

• 1 other identifier: GN20CA408
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Current MRI society guidelines recommend that reference ranges for specific imaging techniques (T1, T2 mapping, perfusion) are acquired on the MRI scanner that clinical work and research studies are being carried out on. We propose to undertake 32 multi parametric stress cardiac MRI scans on healthy volunteers (50% female, 50% male) over the age of 18 years. These measurements are not yet available for the 3.0T Prisma scanner at the Institute of Clinical Excellence (ICE), Queen Elizabeth University Hospital (QEUH). These values are essential to identify what is abnormal for people living in the west of Scotland.

Conditions

Healthy Volunteers

Keywords

cardiovascular magnetic resonance imaging; adenosine stress; parametric mapping; reference ranges; strain; healthy volunteers

Outcome Measures

Primary Outcomes (5)

• Peak stress myocardial blood (mg/ml/min)

  Peak stress myocardial blood with adenosine vasodilator stress

  Through study completion, on average <2years.

• Myocardial perfusion reserve

  Myocardial perfusion reserve with adenosine vasodilator stress

  Through study completion, on average <2years.

• Global and septal T1 (MOLLI, shMOLLI) T2

  reference ranges

  Through study completion, on average <2years.

• Global and regional Circumferential strain (GCS)

  using Displacement Encoding with Stimulated Echoes (DENSE) MRI.

  Through study completion, on average <2years.

• Global and regional Longitudinal strain (GLS)

  using Displacement Encoding with Stimulated Echoes (DENSE) MRI.

  Through study completion, on average <2years.

Interventions

Multiparametric stress CMR protocol DIAGNOSTIC_TEST

Multiparametric stress CMR protocol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers aged at least 18 years with no prior medical history (including cardiovascular health problems, medication or systemic illness including COVID-19) will be invited to participate by i) contacting eligible participants from the Clinical research imaging volunteer bank ii) placing advertisements in public buildings (e.g. hospital, university). Vaccination status for SARS Coronavirus-19 is not an exclusion criterion. The other exclusion criteria include standard contraindications to MRI (e.g. metallic implants and metallic foreign body) and known or suspected pregnancy.

You may qualify if:

• Age 18≥years
• Capacity to provide written informed consent
• Able to comply with study procedures
• eGFR \>45ml/min

You may not qualify if:

• Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body.
• Contra-indication to intravenous adenosine, i.e. severe asthma; long QT syndrome; second- or third-degree AV block and sick sinus syndrome.
• Lack of informed consent.
• Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test
• History of cardiovascular illness.
• Previous COVID-19 illness

Sponsors & Collaborators

• University of Glasgow: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, Lanarkshire, G51 4TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Kenneth Mangion, MD PhD

CONTACT

0141 232 7600; kenneth.mangion@ggc.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Cardiology

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: November 10, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

GB (1)