Comparative Imaging Assessment of Valvular Heart Disease
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: MRI with strain measurement, Echocardiography.
- Кому может быть актуально
- Состояния в реестре: Valve Heart Disease, Aortic Stenosis, Aortic Regurgitation. Базовые параметры: 18 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест MRI with strain measurement
CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis - Диагностический тест Echocardiography
Doppler, PISA, VCA, volumetric method as performed during echocardiography
Первичные конечные точки
- Change in MRI Quantified LVEDVi [Срок оценки: 6 months]
- Change in MRI Quantified LVESVi [Срок оценки: 6 months]
- Change in MRI Quantified LV Strain [Срок оценки: 6 months]
- Change in MRI LVEF [Срок оценки: 6 Months]
- Change in Kansas City Cardiomyopathy Questionnaire Answers [Срок оценки: 6 Months]
- Change in Physical Activity Questionnaire Answers [Срок оценки: 6 Months]
- All-cause mortality [Срок оценки: 6 Months]
- Development of class I or IIa indication for valve surgery [Срок оценки: 6 Months]
Вторичные конечные точки (1)
- Accuracy of echocardiography as compared with MRI [Срок оценки: 6 Months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Cleveland Clinic — Cleveland
Идентификаторы
NCT: NCT04126018 · 19-549