Comparative Imaging Assessment of Valvular Heart Disease
- Conditions
- Aortic StenosisValve Heart DiseaseAortic Regurgitation
- Interventions
- Diagnostic Test: MRI with strain measurementDiagnostic Test: Echocardiography
- Registration Number
- NCT04126018
- Lead Sponsor
- The Cleveland Clinic
- 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 6-12 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mitral Valve Regurgitation Echocardiography Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam. Patients referred for CRT Implantation MRI with strain measurement Patients who meet clinical guideline criteria for CRT implantation with EF \< 40% Aortic Stenosis MRI with strain measurement Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam. Aortic Valve Regurgitation Echocardiography Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam. Patients referred for CRT Implantation Echocardiography Patients who meet clinical guideline criteria for CRT implantation with EF \< 40% Mitral Valve Regurgitation MRI with strain measurement Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam. Aortic Stenosis Echocardiography Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam. Aortic Valve Regurgitation MRI with strain measurement Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.
- Primary Outcome Measures
Name Time Method Change in MRI Quantified LVEDVi 6 months 10% Change from Baseline - units of measure cc/m2
Change in MRI Quantified LV Strain 6 months 5% Change from Baseline
All-cause mortality 6 Months number of patients expired
Change in MRI LVEF 6 Months 5% Change from Baseline
Change in Kansas City Cardiomyopathy Questionnaire Answers 6 Months Change in quality of life related to heart failure symptoms.
Change in MRI Quantified LVESVi 6 months 15% Change from Baseline - units of measure cc/m2
Change in Physical Activity Questionnaire Answers 6 Months Change in physical activity level due to heart failure symptoms.
Development of class I or IIa indication for valve surgery 6 Months The recommended indications for surgery include: development of symptoms, LV dysfunction (LV end-systolic diameter ≥45 mm or LV ejection fraction ≤60%), and new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary artery pressure \>50 mm Hg at rest).
- Secondary Outcome Measures
Name Time Method Accuracy of echocardiography as compared with MRI 6 Months Comparison of MRI measurements based on standard of care echocardiography.
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States