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Starting soon Observational

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

NCT07131111 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-09-01
Last updated
2025-08-20

Condition(s) studied

Aortic GeometryVascular RemodelingCoarctation of AortaBlood PressureResidual StenosisCT AortographyCMRAortic Elasticity and DistensibilityAortic Arch

Investigational drug(s) / intervention(s)

CT aortographyCMR

CT aortography: Performed before and after stenting using a multidetector CT scanner (device model and parameters to be specified). Analysis will include: * Evaluation of aortic arch geometry (normal / gothic / crenel). * Measurement of residual stenosis at the site of coarctation. * Aortic diameter measurements at predefined anatomical levels: Ascending aorta (AA), Proximal descending thoracic aorta (PDA), At the level of the diaphragm (DA), Abdominal aorta (AbAo). \- Aortic tortuosity. All CT data will be interpreted by two independent observers blinded to clinical outcomes

CMR: CMR examinations will be performed using a commercially available 1.5 Tesla whole-body scanner (Ingenia, Philips Healthcare, release 4.1.3.0). In pediatric or uncooperative patients, free-breathing sequences were used when breath-holding was not feasible. Brachial blood pressure was measured in the right arm in the supine position immediately before image acquisition using automated oscillometric devices. Cine steady-state free precession (SSFP) sequences were obtained in multiple views including the short axis of the ascending aorta (AAO) and descending aorta (DAO), as well as the aortic root to evaluate aortic valve morphology (bicuspid vs tricuspid). Left ventricular (LV) and left atrial (LA) functional parameters were assessed by standard volumetric analysis. The following CMR-derived parameters were collected: Left ventricular ejection fraction (LVEF) Left ventricular strain Left ventricular mass index (LVMI) Left atrial volume Left atrial strain LV and LA strain were analyzed usi

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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. Exclusion Criteria: 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.

Primary outcome measure(s)

  • Change in Systolic Blood Pressure — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
Institutional Review Board (IRB) of Faculty of Medicine Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131111 on ClinicalTrials.gov ↗ ← All trials in Egypt