The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field (TITAN)
Primary Purpose
Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance Imaging
Fast Field Cycling - Magnetic Resonance Imaging
Electrocardiogram
Echocardiogram
Sponsored by
About this trial
This is an interventional basic science trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Cardiovascular Research FacilityRecruiting
- University of Aberdeen and NHS GrampianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Myocardial Infarction Group
Healthy Volunteers
Arm Description
Patients diagnosed with a myocardial infarction
Healthy Volunteers
Outcomes
Primary Outcome Measures
Cardiac Magnetic Resonance Imaging
Cardiac Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves
Fast Field Cycling Magnetic Resonance Imaging
Fast Field Cycling Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04458883
Brief Title
The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field
Acronym
TITAN
Official Title
The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field The TITAN Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myocardial Infarction Group
Arm Type
Experimental
Arm Description
Patients diagnosed with a myocardial infarction
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Healthy Volunteers
Intervention Type
Procedure
Intervention Name(s)
Cardiac Magnetic Resonance Imaging
Intervention Description
Cardiac Magnetic Resonance Imaging - Cardiac Scan
Intervention Type
Procedure
Intervention Name(s)
Fast Field Cycling - Magnetic Resonance Imaging
Intervention Description
Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan
Intervention Type
Procedure
Intervention Name(s)
Electrocardiogram
Other Intervention Name(s)
ECG
Intervention Description
Electrocardiogram
Intervention Type
Procedure
Intervention Name(s)
Echocardiogram
Intervention Description
Echocardiogram
Primary Outcome Measure Information:
Title
Cardiac Magnetic Resonance Imaging
Description
Cardiac Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves
Time Frame
At baseline
Title
Fast Field Cycling Magnetic Resonance Imaging
Description
Fast Field Cycling Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Ross, PhD
Phone
01224437832
Email
james.ross@abdn.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Amelia Rudd, MSc
Phone
01224559473
Ext
01224559473
Email
a.e.rudd@abdn.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Dawson, DPhil
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Research Facility
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Rudd, MSc
Phone
01224559473
Ext
01224559473
Email
a.e.rudd@abdn.ac.uk
First Name & Middle Initial & Last Name & Degree
James Ross, PhD
Phone
01224437832
Email
james.ross@abdn.ac.uk
Facility Name
University of Aberdeen and NHS Grampian
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Dawson
Phone
07890095869
Email
stacey.dawson@abdn.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24309067
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.
Results Reference
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PubMed Identifier
6739544
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.
Results Reference
background
PubMed Identifier
22025420
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.
Results Reference
background
PubMed Identifier
22161576
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.
Results Reference
background
PubMed Identifier
30586731
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.
Results Reference
background
PubMed Identifier
28701474
Citation
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.
Results Reference
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The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field
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