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The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field (TITAN)

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ClinicalTrials.gov Identifier: NCT04458883
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Cardiac Magnetic Resonance Imaging Procedure: Fast Field Cycling - Magnetic Resonance Imaging Procedure: Electrocardiogram Procedure: Echocardiogram Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field The TITAN Study
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Myocardial Infarction Group
Patients diagnosed with a myocardial infarction
Procedure: Cardiac Magnetic Resonance Imaging
Cardiac Magnetic Resonance Imaging - Cardiac Scan

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

Experimental: Healthy Volunteers
Healthy Volunteers
Procedure: Cardiac Magnetic Resonance Imaging
Cardiac Magnetic Resonance Imaging - Cardiac Scan

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

Procedure: Electrocardiogram
Electrocardiogram
Other Name: ECG

Procedure: Echocardiogram
Echocardiogram




Primary Outcome Measures :
  1. Cardiac Magnetic Resonance Imaging [ Time Frame: At baseline ]
    Cardiac Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves

  2. Fast Field Cycling Magnetic Resonance Imaging [ Time Frame: At baseline ]
    Fast Field Cycling Magnetic Resonance Imaging - Cardiac Scan to assess cardiac function and T1 dispersion curves



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458883


Contacts
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Contact: James Ross, PhD 01224437832 james.ross@abdn.ac.uk
Contact: Amelia Rudd, MSc 01224559473 ext 01224559473 a.e.rudd@abdn.ac.uk

Locations
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United Kingdom
Cardiovascular Research Facility
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
Investigators
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Principal Investigator: Dana Dawson, DPhil University of Aberdeen
Publications:

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT04458883    
Other Study ID Numbers: 2-010-20
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases