Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MRI

Novel Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MR for Non-Invasive Evaluation of Coronary Artery Disease

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.

Study Overview

• Status: Terminated
• Conditions: Cardiac Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • CMRR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult population with no contraindication to magnetic resonance imaging

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CMR; Subjects with no contraindication to magnetic resonance imaging, who will undergo cardiac MRI scanning.	Drug: MRI Contrast; MRI Contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative comparison of the proposed techniques with existing imaging techniques	vessel length and sharpness	1 and 3 years
infarct size,	quantitative measures	1 and 3 years
left and right ventricular volumes and masses,	quantitative measures	1 and 3 years
time-intensity-curve upslopes,	quantitative measures	1 and 3 years
high-resolution approaches with existing standard resolution imaging technique	quantitative measures	1 and 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of stenosis (yes/no dichotomous)	Qualitative comparison	1 and 3 years
presence of infarct (yes/no dichotomous),	Qualitative comparison	1 and 3 years
image quality (scores range from 1 [poor] to 4 [excellent]).	Qualitative comparison	1 and 3 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Akcakaya M, Basha TA, Chan RH, Manning WJ, Nezafat R. Accelerated isotropic sub-millimeter whole-heart coronary MRI: compressed sensing versus parallel imaging. Magn Reson Med. 2014 Feb;71(2):815-22. doi: 10.1002/mrm.24683.
• Akcakaya M, Basha TA, Pflugi S, Foppa M, Kissinger KV, Hauser TH, Nezafat R. Localized spatio-temporal constraints for accelerated CMR perfusion. Magn Reson Med. 2014 Sep;72(3):629-39. doi: 10.1002/mrm.24963. Epub 2013 Oct 7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimated): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: coronary artery disease; Cardiac MRI; Accelerate imaging
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CMR_CE_WH_AccMRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No