Non-contrast 3-dimensional Cardiac Magnetic Resonance Imaging
1 other identifier
observational
35
1 country
2
Brief Summary
Non-contrast enhanced cardiac MRI using 3D whole heart acquisition protocol is non-inferior to contrast enhanced CT in the assessment of aortic annulus complex for pre-TAVR imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2013
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedAugust 11, 2020
December 1, 2015
1 year
March 3, 2014
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
To compare differences between contrast-enhanced CT and non-contrast enhanced cardiac MRI.(adjusted (by the propensity score) Kappa tests, specificity, and sensitivity will be used to assess agreement between MRI and CT)
using 3D whole heart acquisition protocol. A generalized propensity score (to adjust for pre-operative clinical and non-clinical factors) approach will be used to account for possible confounding of the association between MRI and CT and annulus area, annulus perimeter, and maximum and minimum annulus diameter measurements. Specifically, a general linear (which will account for clustering of data within patients and will include the propensity score) will be developed to assess measurement differences between diagnostic tests. Moreover, adjusted (by the propensity score) Kappa tests, specificity, and sensitivity will be used to assess agreement between MRI and CT
Pre procedure (Baseline)
Eligibility Criteria
The study cohort will consist of 35 patients who are referred for pre-TAVR imaging with arotic valve stenosis who meet the following eligibility criteria and have provided written informed consent.
You may qualify if:
- Patients aged ≥18 years
- Patients with aortic stenosis.
You may not qualify if:
- Pregnancy-Women of childbearing potential should have negative urine pregnancy test prior to enrollment
- Patients with implanted pacemaker
- Patients with implantable cardiac defibrillator
- Patients with contraindication to MRI
- Medically unable to provide consent
- Any surgical prosthesis
- Moderate or severe mitral regurgitation
- Central aortic valve leak
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Center for Advance Cardiac Care
Plano, Texas, 75093, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
August 3, 2020
Study Start
December 1, 2013
Primary Completion
December 5, 2014
Study Completion
December 5, 2014
Last Updated
August 11, 2020
Record last verified: 2015-12