Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MRI

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02550366
Collaborator
(none)
44
1
48.8
0.9

Study Details

Study Description

Brief Summary

Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used in the diagnosis of CAD. In this work, the investigators will develop and validate techniques for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved contrast, and superior spatial and temporal resolutions.

Condition or Disease Intervention/Treatment Phase
  • Drug: MRI Contrast

Detailed Description

Coronary artery disease (CAD) is the leading cause of death in the United States, even though significant efforts have been made in prevention and diagnosis. The clinical gold standard for diagnosis of CAD is catheter-based invasive x-ray angiography, performed more than a million times per year. Of these examinations, up to 35% have been found to have no significant stenosis, yet these patients had to go through the potential risks and complications of an invasive test that further exposes the patient to ionizing radiation and iodinated contrast. Thus, non-invasive diagnostic alternatives are highly desirable.

Cardiac MRI (CMR) provides a method for a comprehensive non-invasive cardiac exam, including contractile functional assessment (cine) to detect wall-motion abnormality, myocardial CMR perfusion for diagnosing perfusion defects, viability assessment using late gadolinium enhancement for evaluation of acute and chronic myocardial infarction, and coronary MRI for the identification of stenosis. CMR is advantageous in several respects, since it does not require ionizing radiation or iodinated contrast, thereby facilitating repeated or follow-up scanning. However, long data acquisition time remains as one of its main limitations. Several approaches have been studied to facilitate rapid CMR acquisition. Nonetheless, the acquisition time for high-resolution CMR remains long, and spatial and temporal resolution is traded off for acquisition time. Therefore, developments of methods to reduce the duration of data acquisition beyond what is available now are appealing. The investigators will develop novel reconstruction methodologies for high-resolution CMR that learn the anatomical structures in the images being reconstructed. The investigators will validate these techniques in a range of contrast-enhanced CMR imaging protocols, providing better volumetric coverage of the heart, efficient use of the contrast agents, and higher spatial and temporal resolution.

Study Design

Study Type:
Observational
Actual Enrollment :
44 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Novel Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MR for Non-Invasive Evaluation of Coronary Artery Disease
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Oct 26, 2020
Actual Study Completion Date :
Oct 26, 2020

Arms and Interventions

Arm Intervention/Treatment
CMR

Subjects with no contraindication to magnetic resonance imaging, who will undergo cardiac MRI scanning.

Drug: MRI Contrast
MRI Contrast

Outcome Measures

Primary Outcome Measures

  1. Quantitative comparison of the proposed techniques with existing imaging techniques [1 and 3 years]

    vessel length and sharpness

  2. infarct size, [1 and 3 years]

    quantitative measures

  3. left and right ventricular volumes and masses, [1 and 3 years]

    quantitative measures

  4. time-intensity-curve upslopes, [1 and 3 years]

    quantitative measures

  5. high-resolution approaches with existing standard resolution imaging technique [1 and 3 years]

    quantitative measures

Secondary Outcome Measures

  1. presence of stenosis (yes/no dichotomous) [1 and 3 years]

    Qualitative comparison

  2. presence of infarct (yes/no dichotomous), [1 and 3 years]

    Qualitative comparison

  3. image quality (scores range from 1 [poor] to 4 [excellent]). [1 and 3 years]

    Qualitative comparison

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • "Healthy" subjects 18 years and older

  • Cardiovascular disease patients referred from the Department of Cardiology, who do not meet any of the exclusion criteria.

Exclusion Criteria:
  • Exclusion criteria include those associated with the use of MR as the imaging modality. Patients with pacemakers, implanted cardioverter-defibrillators, intracerebral clips or other implants that are not MR incompatible, atrial flutter or frequent atrial or ventricular ectopic activity, weight over 250 pounds, or significant claustrophobia will be excluded.

  • Subjects should not have the following which may be hazardous to their health or interfere with MRI examinations: cardiac pacemaker; implanted cardiac defibrillator; carotid artery vascular clamp; intravascular stents, filters, or coils; aortic clip; internal pacing wires; vascular access port and/or catheter; Swan-Ganz catheter; shunt (spinal or intraventricular); aneurysm clip(s); neurostimulator; electrodes (on body, head, or brain);heart valve prosthesis; any type of prosthesis (eye, penile, etc.); artificial limb or joint replacement; bone growth/fusion stimulator; bone/joint pin, screw, nail, wire, plate; metal rods in bones; Harrington rods (spine); metal or wire mesh implants; wire sutures or surgical staples; insulin pump or infusion device; any metal fragments (i.e. metal shop); any implant held in place by a magnet; cochlear, otologic, or ear implant.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CMRR Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Mehmet Akcakaya, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02550366
Other Study ID Numbers:
  • CMR_CE_WH_AccMRI
First Posted:
Sep 15, 2015
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2020