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Quantitative Cardiac Parametric Mapping (Myomapping)

Primary Purpose

Cardiomyopathy, Myocarditis, Ischemic Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance (CMR) imaging techniques
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiomyopathy, Myocarditis, Ischemic Heart Disease focused on measuring myocardial tissue characterization

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must be 18-90 years of age.
  • Subject must be previously diagnosed with or suspected to have one of the following conditions.
  • Myocardial ischemia or infarction (group 1)
  • Hypertrophic cardiomyopathy (group 2)
  • Infiltrative cardiomyopathy (group 3)
  • Myocarditis (group 4)
  • Subject must have been referred for a clinically indicated CMR.

Exclusion Criteria:

  • Subject has any implanted device or condition in which an MR scan would be contraindicated.
  • Subject has an acute psychiatric disorder or is cognitively impaired.
  • Subject is using or is dependent on substances of abuse.
  • Subject is unwilling to comply with the requirements of the protocol.
  • Subject has previously entered this study.
  • Subject has an allergy against MRI contrast agents.
  • Subject is in acute unstable condition.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Additional 5 minute research MR scan of heart.

Arm Description

The purpose of this is to evaluate new, faster MR scans

Outcomes

Primary Outcome Measures

Clinical value of fast T1, T2, and T2* mapping of the left ventricle for the assessment of necrosis/scar, edema, and possible intramyocardial hemorrhage in patients with heart disease.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2016
Last Updated
November 29, 2022
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02855554
Brief Title
Quantitative Cardiac Parametric Mapping
Acronym
Myomapping
Official Title
Novel Magnetic Resonance Imaging Techniques for Quantitative Cardiac Parametric Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2014 (undefined)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

5. Study Description

Brief Summary
The overall goal of this project is to evaluate the clinical potential of fast quantitative myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Myocarditis, Ischemic Heart Disease
Keywords
myocardial tissue characterization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Additional 5 minute research MR scan of heart.
Arm Type
Experimental
Arm Description
The purpose of this is to evaluate new, faster MR scans
Intervention Type
Other
Intervention Name(s)
Cardiac Magnetic Resonance (CMR) imaging techniques
Intervention Description
Evaluation of clinical potential of fast quantitative myocardial tissue characterization using recently emerged CMRI techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases.
Primary Outcome Measure Information:
Title
Clinical value of fast T1, T2, and T2* mapping of the left ventricle for the assessment of necrosis/scar, edema, and possible intramyocardial hemorrhage in patients with heart disease.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must be 18-90 years of age. Subject must be previously diagnosed with or suspected to have one of the following conditions. Myocardial ischemia or infarction (group 1) Hypertrophic cardiomyopathy (group 2) Infiltrative cardiomyopathy (group 3) Myocarditis (group 4) Subject must have been referred for a clinically indicated CMR. Exclusion Criteria: Subject has any implanted device or condition in which an MR scan would be contraindicated. Subject has an acute psychiatric disorder or is cognitively impaired. Subject is using or is dependent on substances of abuse. Subject is unwilling to comply with the requirements of the protocol. Subject has previously entered this study. Subject has an allergy against MRI contrast agents. Subject is in acute unstable condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Ghent, BA
Phone
843-876-7148
Email
ghent@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Giovagnoli, BS
Phone
843-876-4922
Email
giovagnv@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph U. Schoepf, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Martinez, MS
Phone
843-876-7148
Email
martjohn@musc.edu
First Name & Middle Initial & Last Name & Degree
Hunter Gray, BS
Phone
843-876-4922
Email
grayhu@musc.edu
First Name & Middle Initial & Last Name & Degree
Joseph U. Schoepf, MD

12. IPD Sharing Statement

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Quantitative Cardiac Parametric Mapping

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