Comparative Imaging Assessment of Valvular Heart Disease

Aortic Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126018
• Other study ID #: 19-549
• Status: Recruiting
• Start date: August 23, 2019
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: Deborah Kwon, M. D.
• Phone: 216-444-8526
• Email: kwond[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

Diagnostic Test:
• MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
• Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MRI Quantified LVEDVi	10% Change from Baseline - units of measure cc/m2	6 months
Primary	Change in MRI Quantified LVESVi	15% Change from Baseline - units of measure cc/m2	6 months
Primary	Change in MRI Quantified LV Strain	5% Change from Baseline	6 months
Primary	Change in MRI LVEF	5% Change from Baseline	6 Months
Primary	Change in Kansas City Cardiomyopathy Questionnaire Answers	Change in quality of life related to heart failure symptoms.	6 Months
Primary	Change in Physical Activity Questionnaire Answers	Change in physical activity level due to heart failure symptoms.	6 Months
Primary	All-cause mortality	number of patients expired	6 Months
Primary	Development of class I or IIa indication for valve surgery	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).	6 Months
Secondary	Accuracy of echocardiography as compared with MRI	Comparison of MRI measurements based on standard of care echocardiography.	6 Months