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临床试验/NCT07131111
NCT07131111尚未招募不适用

Impact of Aortic Geometry on Vascular Remodeling After Stent Implantation in Coarctation of the Aorta

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Change in Systolic Blood Pressure

研究概览

简要总结

This study aims to assess:

  1. Aortic geometrical changes and their relationship to hypertension and cardiovascular events.
  2. Aortic geometrical differences between healthy individuals and patients with repaired coarctation of the aorta.

详细描述

Coarctation of the aorta (CoA) is a congenital narrowing of the aortic lumen, accounting for 5-8% of congenital heart diseases, with an incidence of 1 in 3000-4000 live births . This narrowing leads to altered hemodynamics, including increased left ventricular afterload, systemic hypertension, and long-term vascular remodeling, which can persist even after anatomical correction .

Despite advances in interventions like stent implantation for native or recurrent CoA, many patients remain hypertensive post-procedure . This residual hypertension may not be purely mechanical but linked to persistent vascular dysfunction, abnormal aortic compliance, or inadequate aortic wall remodeling .

Aortic stiffness is now recognized as a key cardiovascular risk factor in CoA patients . Reduced elasticity contributes to high systolic blood pressure, increased cardiac workload, and late cardiovascular complications [7]. Moreover, abnormal aortic arch geometry-particularly the "gothic arch"-has been linked to impaired vascular function and unfavorable hemodynamics [13].

While cardiac magnetic resonance (CMR) is the standard for evaluating aortic stiffness and ventricular function , CT Aortography offers high-resolution images to assess aortic distensibility, luminal changes, and residual stenosis, especially post-stenting . When combined with blood pressure and ECG data, these insights can provide a fuller picture of outcomes .

This study investigates the relationship between post-stenting blood pressure and aortic geometry-including arch shape and residual stenosis-using CT Aortography in CoA patients. It also explores ECG changes as potential non-invasive markers of ventricular strain and hemodynamic stress ..

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age ≥ 12 years.
  • Diagnosed with native or recurrent coarctation of the aorta.
  • Transcatheter systolic pressure gradient ≥ 20 mmHg.
  • Body weight ≥ 20 kg.
  • Availability of pre- and post-stenting CT aortography data.

排除标准

  • Patients with obstructive lesion of LVOT or aortic valve dysfunction greater than moderate (requiring surgical intervention)..
  • Patients with other causes of secondary hypertension.
  • Associated complex congenital heart defects (aside from simple septal defects and patent ductus arteriosus)
  • Genetic syndromes
  • Connective tissue disorder
  • History of surgery involving the aortic root or ascending aorta.
  • Incomplete imaging or missing data relevant to the study.

结局指标

主要结局

Change in Systolic Blood Pressure

时间窗: Baseline and 6 months post-stenting

Difference in systolic blood pressure between baseline (pre-stenting) and 6 months post-stenting using standardized clinical sphygmomanometer. Unit of Measure: mmHg

Change in Diastolic Blood Pressure

时间窗: Baseline and 6 months post-stenting

Difference in diastolic blood pressure between baseline (pre-stenting) and 6 months post-stenting using standardized clinical sphygmomanometer. Unit of Measure: mmHg

次要结局

  • QTc Dispersion(Baseline and 6 months post-stenting)
  • Presence of Arrhythmia(Baseline and 6 months post-stenting)
  • Aortic Elasticity(Baseline and 6 months post-stenting)
  • Aortic Arch Curvature(Baseline and 6 months post-stenting)
  • LV Mass Index (LVMI)(Baseline and 6 months post-stenting)
  • Aortic Arch Morphology Classification(Baseline (within hospital stay, up to 2 days))
  • Presence of Left Ventricular Hypertrophy on ECG(Baseline and 6 months post-stenting)
  • Aortic Distensibility(Baseline and 6 months post-stenting)
  • Aortic Arch Angle(Baseline and 6 months post-stenting)
  • Residual Stenosis(6 months post-stenting)
  • Left Ventricular Ejection Fraction (LVEF)(Baseline and 6 months post-stenting)
  • LV Global Longitudinal Strain(Baseline and 6 months post-stenting)
  • Left Atrial Volume Index (LAVI)(Baseline and 6 months post-stenting)

研究者

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

Mina wadee fathy

Principal investigator

Assiut University

研究点 (1)

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