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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04458883
Other study ID # 2-010-20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date July 31, 2025

Study information

Verified date May 2023
Source University of Aberdeen
Contact James Ross, PhD
Phone 01224437832
Email james.ross@abdn.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of the study is to build and test a cardiac-specific coil purposely assembled in house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical cardiac scans in human subject populations.


Description:

Aberdeen scientists are at the forefront of a new type of magnetic resonance imaging (MRI), having built in-house the only two available prototypes of Fast Field-Cycling MRI in the world - and these already have clinical imaging capabilities. Fast Field-Cycling MRI switches rapidly over a range of field strengths (0.2 T to 200 µT), providing a T1 dispersion curve. This information is invisible to fixed-field scanners and uncovers unique knowledge about motion and interaction between component molecules within a tissue (i.e. water/fat/proteins). In this application the investigators wish to use their in-house expertise further to extend the capability of our Fast Field-Cycling MRI to perform cardiac imaging by building the first-ever cardiac Fast Field-Cycling MRI coil and develop cardiac pulse sequences with ECG gating. The investigators will aim to establish the normalcy of T1 dispersion curves for left ventricular myocardium in healthy volunteers, and further on to distinguish the characteristics of post-myocardial infarction scar T1 dispersion curves.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Participant who is willing and able to give informed consent for participation in the study - Healthy volunteers willing to give informed consent for participation in the study - Patients diagnosed with a previous myocardial infarction Exclusion Criteria: - Unwillingness to participate - Claustrophobia - Contraindication to MRI scanning such as implantable cardiac devices - Participants who have had a previous myocardial infarction in the past of which they may not be aware and this is discovered whilst being scanned on the 3T MRI scanner, or who may have any other cardiology condition that they were previously unaware will not be included in the healthy control group, even if they present themselves to us as "healthy" at the time of the study visit - Pregnancy - Body habitus that may preclude comfortable positioning of the volunteer in either of the MRI scanners (>50cm in diameter) - Participants with abnormal kidney function that will preclude them from receiving a contrast agent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac Magnetic Resonance Imaging
Cardiac Magnetic Resonance Imaging - Cardiac Scan
Fast Field Cycling - Magnetic Resonance Imaging
Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan
Electrocardiogram
Electrocardiogram
Echocardiogram
Echocardiogram

Locations

Country Name City State
United Kingdom Cardiovascular Research Facility Aberdeen Aberdeenshire
United Kingdom University of Aberdeen and NHS Grampian Aberdeen Aberdeenshire

Sponsors (1)

Lead Sponsor Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Antonopoulos AS, Sanna F, Sabharwal N, Thomas S, Oikonomou EK, Herdman L, Margaritis M, Shirodaria C, Kampoli AM, Akoumianakis I, Petrou M, Sayeed R, Krasopoulos G, Psarros C, Ciccone P, Brophy CM, Digby J, Kelion A, Uberoi R, Anthony S, Alexopoulos N, Tousoulis D, Achenbach S, Neubauer S, Channon KM, Antoniades C. Detecting human coronary inflammation by imaging perivascular fat. Sci Transl Med. 2017 Jul 12;9(398):eaal2658. doi: 10.1126/scitranslmed.aal2658. — View Citation

Broche LM, Ashcroft GP, Lurie DJ. Detection of osteoarthritis in knee and hip joints by fast field-cycling NMR. Magn Reson Med. 2012 Aug;68(2):358-62. doi: 10.1002/mrm.23266. Epub 2011 Dec 12. — View Citation

Broche LM, Ismail SR, Booth NA, Lurie DJ. Measurement of fibrin concentration by fast field-cycling NMR. Magn Reson Med. 2012 May;67(5):1453-7. doi: 10.1002/mrm.23117. Epub 2011 Oct 24. — View Citation

Broche LM, Ross PJ, Pine KJ, Lurie DJ. Rapid multi-field T(1) estimation algorithm for Fast Field-Cycling MRI. J Magn Reson. 2014 Jan;238:44-51. doi: 10.1016/j.jmr.2013.10.010. Epub 2013 Oct 31. — View Citation

Kimmich R, Nusser W, Winter F. In vivo NMR field-cycling relaxation spectroscopy reveals 14N1H relaxation sinks in the backbones of proteins. Phys Med Biol. 1984 May;29(5):593-6. doi: 10.1088/0031-9155/29/5/011. No abstract available. — View Citation

Scally C, Abbas H, Ahearn T, Srinivasan J, Mezincescu A, Rudd A, Spath N, Yucel-Finn A, Yuecel R, Oldroyd K, Dospinescu C, Horgan G, Broadhurst P, Henning A, Newby DE, Semple S, Wilson HM, Dawson DK. Myocardial and Systemic Inflammation in Acute Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2019 Mar 26;139(13):1581-1592. doi: 10.1161/CIRCULATIONAHA.118.037975. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac Magnetic Resonance Imaging Cardiac Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves At baseline
Primary Fast Field Cycling Magnetic Resonance Imaging Fast Field Cycling Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves At baseline
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