An observational study in Aortic Geometry, Vascular Remodeling and Coarctation of Aorta, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Assiut University · Observational
This study aims to assess:
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 ..
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of two groups:
All participants will undergo imaging and functional evaluation including CT aortography, cardiac MRI, 24-hour ambulatory blood pressure monitoring (ABPM), and ECG as part of the study protocol.
The study will be conducted at [Assiut University Hospital / Orman Cardiology Center - modify as needed], and participants will be recruited from the cardiology outpatient clinics and imaging units.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Radiation: CT aortography · Radiation: CMR
Radiation: 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 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
Change in Systolic Blood Pressure
Difference in systolic blood pressure between baseline (pre-stenting) and 6 months post-stenting using standardized clinical sphygmomanometer. Unit of Measure: mmHg
Time frame: Baseline and 6 months post-stenting
Change in Diastolic Blood Pressure
Difference in diastolic blood pressure between baseline (pre-stenting) and 6 months post-stenting using standardized clinical sphygmomanometer. Unit of Measure: mmHg
Time frame: Baseline and 6 months post-stenting
Aortic Arch Morphology Classification
Classification of aortic arch morphology (normal, gothic, crenel) based on CT aortography. Unit of Measure: Categorical (normal/gothic/crenel)
Time frame: Baseline (within hospital stay, up to 2 days)
Aortic Elasticity
Aortic 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
Time frame: Baseline and 6 months post-stenting
Aortic Distensibility
Aortic distensibility measured from CT aortography. Unit of Measure: mmHg-¹
Time frame: Baseline and 6 months post-stenting
Aortic Arch Angle
Aortic arch angle measured from CT aortography. Unit of Measure: degrees
Time frame: Baseline and 6 months post-stenting
Aortic Arch Curvature
Curvature of the aortic arch measured from CT aortography. Unit of Measure: cm-¹
Time frame: Baseline and 6 months post-stenting
Residual Stenosis
Percentage of luminal narrowing remaining after stent implantation measured by CT angiography. Unit of Measure: %
Time frame: 6 months post-stenting
Left Ventricular Ejection Fraction (LVEF)
Description: LVEF measured by cardiac MRI. Unit of Measure: %
Time frame: Baseline and 6 months post-stenting
LV Global Longitudinal Strain
LV global longitudinal strain measured by cardiac MRI. Unit of Measure: %
Time frame: Baseline and 6 months post-stenting
LV Mass Index (LVMI)
LV mass indexed to body surface area measured by cardiac MRI. Unit of Measure: g/m²
Time frame: Baseline and 6 months post-stenting
Left Atrial Volume Index (LAVI)
Description: Left atrial volume indexed to body surface area measured by cardiac MRI. Unit of Measure: mL/m²
Time frame: Baseline and 6 months post-stenting
QTc Dispersion
QTc dispersion measured from 12-lead ECG using Bazett's formula. Unit of Measure: milliseconds
Time frame: Baseline and 6 months post-stenting
Presence of Left Ventricular Hypertrophy on ECG
Detection of LV hypertrophy based on standard ECG voltage criteria. Unit of Measure: Categorical (present/absent)
Time frame: Baseline and 6 months post-stenting
Presence of Arrhythmia
Detection of arrhythmias using standard 12-lead ECG or Holter monitoring. Unit of Measure: Categorical (present/absent)
Time frame: Baseline and 6 months post-stenting
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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