跳至主要内容
临床试验/NCT04126018
NCT04126018
招募中
不适用

Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 200 人2019年8月23日

概览

阶段
不适用
干预措施
MRI with strain measurement
疾病 / 适应症
Valve Heart Disease
发起方
The Cleveland Clinic
入组人数
200
试验地点
1
主要终点
Change in MRI Quantified LVEDVi
状态
招募中
最后更新
3个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2019年8月23日
结束日期
2027年12月31日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Deborah Kwon, MD

Principal Investigator

The Cleveland Clinic

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Mitral Valve Regurgitation

Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.

干预措施: MRI with strain measurement

Mitral Valve Regurgitation

Patients with moderate or severe (3+ or 4+) mitral valve regurgitation on the basis of prior known clinical history or clinical exam.

干预措施: Echocardiography

Aortic Valve Regurgitation

Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.

干预措施: MRI with strain measurement

Aortic Valve Regurgitation

Patients with moderate or severe (3+ or 4+) aortic valve regurgitation on the basis of prior known clinical history or clinical exam.

干预措施: Echocardiography

Aortic Stenosis

Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.

干预措施: MRI with strain measurement

Aortic Stenosis

Patients with moderate or severe (3+ or 4+) aortic stenosis on the basis of prior known clinical history or clinical exam.

干预措施: Echocardiography

Patients referred for CRT Implantation

Patients who meet clinical guideline criteria for CRT implantation with EF \< 40%

干预措施: MRI with strain measurement

Patients referred for CRT Implantation

Patients who meet clinical guideline criteria for CRT implantation with EF \< 40%

干预措施: Echocardiography

结局指标

主要结局

Change in MRI Quantified LVEDVi

时间窗: 6 months

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

Change in MRI Quantified LV Strain

时间窗: 6 months

5% Change from Baseline

All-cause mortality

时间窗: 6 Months

number of patients expired

Change in MRI LVEF

时间窗: 6 Months

5% Change from Baseline

Change in Kansas City Cardiomyopathy Questionnaire Answers

时间窗: 6 Months

Change in quality of life related to heart failure symptoms.

Change in MRI Quantified LVESVi

时间窗: 6 months

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

Change in Physical Activity Questionnaire Answers

时间窗: 6 Months

Change in physical activity level due to heart failure symptoms.

Development of class I or IIa indication for valve surgery

时间窗: 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).

次要结局

  • Accuracy of echocardiography as compared with MRI(6 Months)

研究点 (1)

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