New Imaging-Derived Biomarkers Based On Tridimensional CTA/MRI Hybrid Models For Complex Assessment Of Myocardial Viability After Myocardial Infarction-the HYBRIDHEART Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hybrid imaging
研究概览
简要总结
The aim of HYBRIDHEART study is to develop new imagistic prototype for a complex evaluation of the myocardial viability by superposing computed tomographic angiographic polar maps of the myocardium with magnetic resonance imaging contractile maps in subjects who suffered an acute myocardial infarction. Moreover, the study will evaluate the association of myocardial viability with the level of inflammatory markers and the percent of myocardial fibrosis, also will correlate the imaging-derived parameters with the inflammatory status of the patients, left ventricular function, ischemic time and major adverse cardiovascular events (MACE) rate.
详细描述
The HYBRIDHEART study is a prospective, observational study that will be conducted in the Laboratory of Advanced Research in Cardiac Multimodal Imaging of Cardio Med Medical Center Tîrgu Mureş, Romania.
The project will include 100 subjects with documented ST Segment elevation myocardial infarction at 30 days prior to study enrollment. The level of inflammatory biomarkers will be express using hs-CRP levels at day 1 and day 5 post the acute event. All the subjects will undergo coronary computer tomography angiography (CCTA), magnetic resonance (MRI), 3D contrast enhancement echocardiography, speckle tracking echocardiography at the moment of the inclusion. Also, venous blood samples will be collected for the determination of the level of hs-CRP and myocardial necrosis biomarkers such as I Troponin, myocardial fraction of creatine kinase (CK-MB).
The imagistic acquisitions obtained from all the techniques used, will be processed using a supercomputer set up with computational simulations applications for the myocardial kinetics. All the MRI images will be analyzed using Medis Q-mass software in order to quantify the myocardial fibrosis, and the CCTA images will be analyzed using SyngoVia. Frontier software, for the plaques evaluation. The images will be superposed obtaining hybrid CCTA-MRI images that will be analyzed in order to correlate the degree of plaque vulnerability, the percent of myocardial scar, the percent of viable myocardial tissue, calculating the total Calcium Scoring, Syntax score.
The study will be conducted over a period of 2 years, in which the subjects will be examined at the moment of inclusion and during the follow-up visits. Will be performed the follow up of the subjects at 1, 3 and 6 months and 1 year after the inclusion period. At 1 month follow up the subjects will be examined, will be performed echocardiography. Moreover during follow up will be done telephonic visits with target questions . MACE rate will be assessed at 6 month follow-up and 1 year follow up visits.
Study objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 18 years old
- •Patients with documented ST segment Elevation Myocardial Infarction in the last 30 days
- •Patients who signed the written consent.
排除标准
- •Subjects with renal impairment, or contrast intolerance
- •Pregnant women
- •Patients known with malignancy in the last year
- •Non-compliant patients
- •Patients older than 90 years
结局指标
主要结局
Hybrid imaging
时间窗: 6 months
the development of the new hybrid imaging features: plaque vulnerability degree, % of myocardial scar, % of viable myocardial tissue
次要结局
- Correlations(12 months)