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临床试验/NCT07799363
NCT07799363招募中不适用

Validering av genomblödning Och extracellulärvolym i hjärtmuskeln Med datortomografiundersökning Hos Patienter Som Ska genomgå Perkutan Aortaklaffbyte (TAVI)

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月10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
100
试验地点
1
主要终点
Agreement Between Photon-Counting CT and Cardiac Magnetic Resonance for Myocardial Perfusion Assessment

研究概览

简要总结

Cardiovascular diseases are the leading cause of death worldwide, responsible for about 30% of all deaths. This substantial burden highlights the need for accurate diagnostic tools that help doctors detect heart disease early and understand it more fully. Recent advances in medical imaging offer promising opportunities to improve how heart conditions are diagnosed and treated.

One important development in computed tomography (CT), a widely used imaging technique, is photon counting computed tomography (PCCT). PCCT produces clearer and more detailed images of the heart while using lower radiation doses and smaller amounts of contrast agent, the dye injected into the bloodstream to make body tissues more visible. As PCCT is still a relatively new technology, its full potential in clinical heart imaging has not yet been fully explored.

This study includes patients with narrowing of the aortic valve, a condition that reduces blood flow from the heart and often requires treatment. These patients undergo cardiac CT before receiving a minimally invasive valve replacement procedure called transcatheter aortic valve implantation (TAVI). The study evaluates two diagnostic applications of PCCT:

Functional assessment: Blood flow to the heart muscle is examined during stress imaging, when the heart works harder, to determine whether narrowed coronary arteries significantly limit blood supply.

Tissue characterization: The heart muscle is analyzed to detect scarring or fibrosis by measuring the extracellular volume (ECV), the space between cells.

If successful, PCCT could provide detailed anatomical, functional, and tissue information in a single non invasive examination, offering a "one stop shop" for comprehensive heart assessment.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred for TAVI planning CTA. Both sexes are eligible; equal sex distribution is not required. Age ≥ 60 years.

排除标准

  • - Hemodynamic or rhythm related conditions: Systolic blood pressure < 90 mmHg. Bradycardia: < 45 beats/min. Persistent AV block II-III. Sick sinus syndrome. Prolonged QT interval. Atrial fibrillation. Severe heart failure: NYHA class IV.
  • Contrast or kidney relaterad factors: Previous allergic reaction to iodinated or gadolinium contrast or history of contrast induced nephropathy. Impaired renal function: eGFR < 45 mL/min/1.73 m².
  • Implants or devices: Metallic implants or devices in the imaging area, e.g., pacemaker. Medication: Persantin (dipyridamole), Theophyllamine, Fevarin (fluvoxamine).

结局指标

主要结局

Agreement Between Photon-Counting CT and Cardiac Magnetic Resonance for Myocardial Perfusion Assessment

时间窗: At baseline imaging assessment

Agreement Between Photon-Counting CT and Cardiac Magnetic Resonance for Extracellular Volume Quantification

时间窗: At baseline imaging assessment

次要结局

未报告次要终点

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raquel Themudo

MD, PhD

Karolinska University Hospital

研究点 (1)

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