Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07131111
Enrollment
50
Registered
2025-08-20
Start date
2025-09-01
Completion date
2026-12-31
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Arch, Aortic Elasticity and Distensibility, Aortic Geometry, Blood Pressure, CMR, Coarctation of Aorta, CT Aortography, Residual Stenosis, Vascular Remodeling

Brief 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.

Detailed description

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 ..

Interventions

RADIATIONCT 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

RADIATIONCMR

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Systolic Blood PressureBaseline and 6 months post-stentingDifference 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 PressureBaseline and 6 months post-stentingDifference in diastolic blood pressure between baseline (pre-stenting) and 6 months post-stenting using standardized clinical sphygmomanometer. Unit of Measure: mmHg

Secondary

MeasureTime frameDescription
Aortic DistensibilityBaseline and 6 months post-stentingAortic distensibility measured from CT aortography. Unit of Measure: mmHg-¹
Aortic Arch AngleBaseline and 6 months post-stentingAortic arch angle measured from CT aortography. Unit of Measure: degrees
Aortic Arch CurvatureBaseline and 6 months post-stentingCurvature of the aortic arch measured from CT aortography. Unit of Measure: cm-¹
Residual Stenosis6 months post-stentingPercentage of luminal narrowing remaining after stent implantation measured by CT angiography. Unit of Measure: %
Left Ventricular Ejection Fraction (LVEF)Baseline and 6 months post-stentingDescription: LVEF measured by cardiac MRI. Unit of Measure: %
Aortic Arch Morphology ClassificationBaseline (within hospital stay, up to 2 days)Classification of aortic arch morphology (normal, gothic, crenel) based on CT aortography. Unit of Measure: Categorical (normal/gothic/crenel)
LV Mass Index (LVMI)Baseline and 6 months post-stentingLV mass indexed to body surface area measured by cardiac MRI. Unit of Measure: g/m²
Left Atrial Volume Index (LAVI)Baseline and 6 months post-stentingDescription: Left atrial volume indexed to body surface area measured by cardiac MRI. Unit of Measure: mL/m²
QTc DispersionBaseline and 6 months post-stentingQTc dispersion measured from 12-lead ECG using Bazett's formula. Unit of Measure: milliseconds
Presence of Left Ventricular Hypertrophy on ECGBaseline and 6 months post-stentingDetection of LV hypertrophy based on standard ECG voltage criteria. Unit of Measure: Categorical (present/absent)
Presence of ArrhythmiaBaseline and 6 months post-stentingDetection of arrhythmias using standard 12-lead ECG or Holter monitoring. Unit of Measure: Categorical (present/absent)
LV Global Longitudinal StrainBaseline and 6 months post-stentingLV global longitudinal strain measured by cardiac MRI. Unit of Measure: %
Aortic ElasticityBaseline and 6 months post-stentingAortic elasticity calculated from CT aortography using (ΔA/A)/ΔP, where A is cross-sectional area and P is pulse pressure. Unit of Measure: mm²/mmHg

Countries

Egypt

Contacts

Primary ContactMena Wadee, Resident doctor
menawade399@gmail.com01282210873
Backup ContactNoha Gamal
noha_cardio@aun.edu.eg+201002295166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026