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NCT Number: NCT04126018

Comparative Imaging Assessment of Valvular Heart Disease

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Christopher Nguyen, Ph.D

SUB_INVESTIGATOR

Deborah Kwon, M. D.

CONTACT

[email protected]

216-444-8526

Mina Chung, MD

SUB_INVESTIGATOR

Richard Grimm, MD

SUB_INVESTIGATOR

Tiffany Dong, MD

SUB_INVESTIGATOR

Tom Wang, MD

SUB_INVESTIGATOR

Wlson Tang, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI with strain measurement

Diagnostic Test

CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis

Echocardiography

Diagnostic Test

Doppler, PISA, VCA, volumetric method as performed during echocardiography

Primary outcomes

  1. Change in MRI Quantified LVEDVi

    Time frame: 6 months

    10% Change from Baseline - units of measure cc/m2

  2. Change in MRI Quantified LVESVi

    Time frame: 6 months

    15% Change from Baseline - units of measure cc/m2

  3. Change in MRI Quantified LV Strain

    Time frame: 6 months

    5% Change from Baseline

  4. Change in MRI LVEF

    Time frame: 6 Months

    5% Change from Baseline

  5. Change in Kansas City Cardiomyopathy Questionnaire Answers

    Time frame: 6 Months

    Change in quality of life related to heart failure symptoms.

  6. Change in Physical Activity Questionnaire Answers

    Time frame: 6 Months

    Change in physical activity level due to heart failure symptoms.

  7. All-cause mortality

    Time frame: 6 Months

    number of patients expired

  8. Development of class I or IIa indication for valve surgery

    Time frame: 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 outcomes

  1. Accuracy of echocardiography as compared with MRI

    Time frame: 6 Months

    Comparison of MRI measurements based on standard of care echocardiography.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Kwon, M. D.

CONTACT

[email protected]

216-444-8526

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2019
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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