Comparative Imaging Assessment of Valvular Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI with strain measurement, Echocardiography.
- Who it may be relevant to
- Registry conditions: Valve Heart Disease, Aortic Stenosis, Aortic Regurgitation. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study
Overview
The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.
Detailed description
The objective of this study is to compare the accuracy of 3D TTE to 2D TTE in assessing the severity of valvular heart disease in patients with aortic stenosis, aortic regurgitation, and mitral valve regurgitation by comparing this to the reference standard of cardiac magnetic resonance (CMR) in subjects with different etiologies and mechanisms of valvular lesions and to the integrative method of valvular lesion grading as recommended by inter-societal guidelines. Another objective is to assess prevalence of focal and diffuse myocardial fibrosis as assessed by CMR in patients with aortic stenosis, aortic regurgitation and mitral regurgitation. In addition, the investigators aim to determine whether severity of myocardial fibrosis predicts onset of symptoms, referral for valve surgery and adverse ventricular remodeling. The investigators also aim to look at patients who will be undergoing CRT implant to predict their response to therapy.
At baseline, the Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire will be completed. A 6-12 month follow-up is required and will include an abbreviated non-contrast research cardiac MRI and subject questionnaires.
Other follow-up will include using electronic medical records and the Social Security Death Index database for outcomes such as death, hospitalization for heart failure, mitral or aortic valve interventions and cardiovascular death.
Select patients will be asked to undergo a supine bicycle exercise stress MRI at enrollment. Approximately 40 subjects will be included in this substudy.
Additional exclusion criteria for this substudy:
* Unable to pedal a supine bicycle * Require supplemental oxygen
During the exercise stress MRI, patients will be asked to cycle on a supine bike that will be mounted on the MRI platform. During this test, a caregiver will be present. An electrocardiogram (ECG) will be used to obtain tracings of cardiac activity. Respirations, blood pressure, and heart rate are also monitored during exercise. The test is continued until peak exercise level or target heart rate is achieved. As soon as the exercise portion is complete, MRI images will be acquired. When the test is complete, patients will be monitored until ECG, heart rate, and breathing have returned to baseline. Patients will be assessed for symptoms such as chest pain, dyspnea, leg pain, dizziness, or fatigue and may be given medications or instructed to stop the test early as necessary.
Interventions
- Diagnostic test MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis - Diagnostic test Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Primary outcome measures
- Change in MRI Quantified LVEDVi [Time frame: 6 months]
- Change in MRI Quantified LVESVi [Time frame: 6 months]
- Change in MRI Quantified LV Strain [Time frame: 6 months]
- Change in MRI LVEF [Time frame: 6 Months]
- Change in Kansas City Cardiomyopathy Questionnaire Answers [Time frame: 6 Months]
- Change in Physical Activity Questionnaire Answers [Time frame: 6 Months]
- All-cause mortality [Time frame: 6 Months]
- Development of class I or IIa indication for valve surgery [Time frame: 6 Months]
Secondary outcome measures (1)
- Accuracy of echocardiography as compared with MRI [Time frame: 6 Months]
Eligibility criteria
Inclusion criteria
- Age 18-90 years of age
- Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.
- Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction
Exclusion criteria
- Acute traumatic cardiac injury
- Aortic dissection or aortic root rupture
- Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
- Presence of A-V fistula or intracardiac shunts
- Any contraindications to CMR
- Moderate or severe dysfunction in multiple valves
- Patients with significant claustrophobia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT04126018 · 19-549