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临床试验/NCT05751057
NCT05751057招募中不适用

The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction: the TITAN-MRI Study

Cardiocentro Ticino2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
Reclassification rate

研究概览

简要总结

The goal of this prospective study is to evaluate the role of cardiovascular magnetic resonance (CMR) in patients with suspected non-ST elevation myocardial infarction (NSTEMI). The main endpoint is the reclassification rate, defined as the number of patients in whom the information provided by pre-angiography CMR affects the revascularization strategy or the final diagnosis.

Participants will undergo to CMR before invasive coronary angiography (ICA).

详细描述

All patients with NSTEMI eligible for the study undergo CMR prior to ICA. To avoid any delay in patients' treatment all examination will be analyzed by local trained staff at each center. All patients will thereafter undergo ICA and the standard of care (SOC) decision-making on revascularization strategy and diagnosis will be declared by the treating physician, which will be blinded to the participation of the patients in the study and about CMR results. The treating physician will also declare patient's next management according to ICA results. After having declared the diagnosis, the treating physician will then be informed about the CMR findings. Therefore, according to CMR results the treating physician may eventually modify the initial diagnosis and management. Treatment plan modifications include difference in the identification of the culprit lesion, referring the patient to medical therapy instead of a revascularization procedure or viceversa, switching from a percutaneous to a surgical revascularization procedure or viceversa, or need for further cardiac or non-cardiac investigations. Initial diagnosis includes confirmed NSTEMI or all other possible alternative diagnosis and proposed additional diagnostic examination(s) for further differential diagnosis.

The CMR-modified SOC (CMR-SOC) and diagnosis made considering CMR results will be collected.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Age > 18 years old
  • Presence of criteria for acute myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction:
  • Signs and symptoms of myocardial ischemia
  • Detection of acute myocardial injury defined as a rise and/or fall of high-sensitivity cardiac Troponin (hs-cTn) values with at least one value above the 99th percentile Upper Reference Limit at baseline or after presentation.
  • Patients scheduled for ICA.
  • Written informed consent.

排除标准

  • Patients diagnosed with myocardial infarction with ST segment elevation.
  • Very High-risk NSTEMI patients according to 2020 ESC Guidelines on Acute Coronary Syndromes:
  • Haemodynamic instability
  • Cardiogenic shock
  • Recurrent/refractory chest pain despite medical treatment
  • Life-threatening arrhythmias
  • Mechanical complications of MI
  • Acute heart failure clearly related to NSTEMI
  • ST-segment depression>1mm/6 leads plus ST-segment elevation aVR and/or V
  • Legally incompetent to provide informed consent
  • Participation in another clinical study.
  • Regular known contraindications to CMR at time of inclusion such as:
  • Severe renal impairment (eGFR < 30 ml / min / 1,73 m2) or on dialysis treatment
  • Claustrophobia
  • Known pregnancy or breast-feeding patients
  • Non MR compatible devices
  • Known allergy to Gadolinium

结局指标

主要结局

Reclassification rate

时间窗: immediately after invasive coronary angiography

number of patients in whom the information provided by CMR affects the final diagnosis

次要结局

  • Culprit lesion identification(during invasive coronary angiography)
  • Revascularization strategy(immediately after invasive coronary angiography)

研究者

发起方
Cardiocentro Ticino
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Giulia Pavon

Consultant Cardiologist, Cardiovascular Imaging Laboratory

Cardiocentro Ticino

研究点 (2)

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