跳至主要内容
临床试验/NCT06029400
NCT06029400招募中不适用

CT-based Myocardial Characterization

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2020年10月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
2,200
试验地点
1
主要终点
Composite outcome

研究概览

简要总结

The identification of myocardial fibrosis in term of myocardial scar and extracellular matrix remodelling assessed respectively with the technique of Late Gadolinium Enhancement (LGE) and with the quantification of the Extracellular Volume Fraction (ECV) in Cardiac Magnetic Resonance has been demonstrated to be crucial in the diagnosis of different cardiomyopathy and to be prognosticators of major cardiovascular adverse events [1-14].

For these reason CMR represent the gold standard for the non-invasive characterization of myocardial tissue in the clinical practice.

However, regardless of its indisputable clinical role, CMR has many limitations: 1) it does not allow to evaluate coronary arteries; 2) it is contraindicated in patients with cardiac devices, and in case of conditional device they may also significantly impair LGE assessability due to artefacts [19]); 2) has limited availability and it is time consuming, therefore it is difficult to perform in the acute setting also because of poor patient compliance; 3) it is not feasible in patients suffering from claustrophobia. Cardiac Computed Tomography (cCT) is the image of choice to non-invasively study coronary arteries, not assessable with CMR. Moreover the recent technological advancement has continuously increased the clinical indication to the evaluation of cardiac valve and fibrosis, with reduced acquisition time respect to CMR (few minutes vs 1 hour), radiation exposure and costs.

cCT has emerging as a possible alternative to CMR in the characterization of myocardial scar and extracellular volume fraction, with the advantage of a single shot evaluation of coronary arteries and myocardial tissue remodelling (scar, diffuse fibrosis, contractility..).In particular, several studies including some from our group, have demonstrated the clinical utility of myocardial tissue characterization with cCT in different clinical settings, such as myocardial infarction [20, 21], myocarditis [22], hypertrophic cardiomyopathy (HCM) [23], heart failure [24], ventricular tachycardia [25], and sarcoidosis [26]. Despite the interesting results, all these previous studies are limited on highly selected and small sample size. Moreover, any large study with long term follow-up is available in the setting of tissue characterization (myocardial scar and ECV) in cCT also as well as combined with a multiparametric approach (cardiac chamber morphofuntionality,contractility-strain, valve calcification, geometry, coronary atherosclerosis, myocardial perfusion, myocardial strain and texture) and no data are available about its prognostic impact. Aim of the study is to evaluate the potential of cCT in tissue characterization (myocardial scar and ECV) alone and associate to other CT imaging biomarker on a large population of patient clinically candidate to cardiac CT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 18 years;
  • no contraindication to cCT
  • signed informed consent
  • clinical indication to cCT for the following reason: stable angina, heart failure, atrial/ ventricular arrhythmias, acute chest pain with need of "triple-rule-out" scan, planning of valvular repair/substitution, structural and infiltrative cardiomyopathy, new onset ECG alteration, troponin increase.

排除标准

  • age < 18 years
  • pregnancy and/or breastfeeding
  • contraindications to iodinated contrast agent administration or impaired renal function (eGFR ≤ 30 mL/min);
  • inability to sustain a brief breath hold (5 seconds)

研究组 & 干预措施

Retrospective cohort

The retrospective arm of the study will include 200 patients meeting the inclusion criteria who have received a cardiac CT from January 2013 to date of approval amendment. (2013 was chosen as starting year to retrieve CT and clinical date in order to have at least 5 years of follow-up per patients).

Prospective cohort

The prospective arm of the study will include 2000 consecutive patients meeting the inclusion criteria, candidate to cardiac CT along the 7 years after date of approval.

结局指标

主要结局

Composite outcome

时间窗: 60 months

first hospitalization for heart failure (HHF) or death (all-cause mortality).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Esposito

Professor

IRCCS San Raffaele

研究点 (1)

Loading locations...

相似试验