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临床试验/NCT03152825
NCT03152825Unknown不适用

Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions

Ospedale San Donato1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年5月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Left ventricular mechanical improvement after PCI

研究概览

简要总结

A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%. Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of CTO lesions leads to improved symptoms, functional class, quality of life, higher left ventricular ejection fraction and improved survival in several observational studies. However, due to the higher rate of procedural complications and lower success rate of PCI than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related complications and identify patients who might benefit most from myocardial revascularization, individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death or MI of ~5%/year) and plausibly represent the best target for PCI.

Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability. Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE >75% of transmurality do not show any improvement in contractility even after revascularization, representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic segments, contractility improvement at low dose dobutamine may predict functional recovery in the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying perfusion defects during pharmacological-induced hyperemia and/or regional wall motion abnormalities during inotrope infusion.

This study is designed to verify the hypothesis that myocardial ischaemia and viability assessed by CMR could identify patients who are more likely to benefit from PCI in terms of improvement in left ventricular remodeling, functional recovery and clinical outcome.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Angiographic diagnosis of Coronary Chronic Total Occlusion (TIMI 0 lasting more than 3 months, if known)
  • baseline stress CMR
  • signed informed consent

排除标准

  • CMR contraindications
  • severe CKD
  • contraindications to adenosine or dobutamine
  • unable/unwilling to sign informed consent
  • pregnancy

结局指标

主要结局

Left ventricular mechanical improvement after PCI

时间窗: 12 +/- 3 months

At least ONE of the following: * Delta ejection fraction ≥ 5% * Segmental function improvement ≥1 grade * Delta end-diastolic volume ≥ 10% * Delta end-systolic volume ≥ 10%

次要结局

  • Quality of life assessed by Seattle Angina Questionnaire (SAQ)(12+/-3 months)
  • Stress ischaemia improvement after PCI(12 +/- 3 months)
  • Major cardiovascular events(12+/- 3 months)

研究者

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

Massimo Lombardi

Director of Multimodality Cardiac Imaging Unit

Ospedale San Donato

研究点 (1)

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