Brief Title
Comparative Imaging Assessment of Valvular Heart Disease
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
Brief Summary
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 month follow-up is required and will
include an abbreviated non-contrast research cardiac MRI and subject questionnaires. At 1
year, subject questionnaires will again be required.
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.
Study Type
Observational
Primary Outcome
Change in MRI Quantified LVEDVi
Secondary Outcome
Accuracy of echocardiography as compared with MRI
Condition
Valve Heart Disease
Intervention
MRI with strain measurement
Study Arms / Comparison Groups
Mitral Valve Regurgitation
Description: Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
200
Start Date
August 23, 2019
Completion Date
December 31, 2022
Primary Completion Date
June 30, 2022
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
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Deborah Kwon, M. D., 216-444-8526, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04126018
Organization ID
19-549
Responsible Party
Principal Investigator
Study Sponsor
The Cleveland Clinic
Study Sponsor
Deborah Kwon, M. D., Principal Investigator, The Cleveland Clinic
Verification Date
October 2020