Institutional Review Board (IRB) of Faculty of Medicine
Asyut, Egypt
NCT Number: NCT07131111
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.
Trial opening soon.
Get Notified12 year and older
All sexes
Observational
Asyut, Egypt
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 ..
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Performed before and after stenting using a multidetector CT scanner (device model and parameters to be specified).
Analysis will include:
Ascending aorta (AA), Proximal descending thoracic aorta (PDA), At the level of the diaphragm (DA), Abdominal aorta (AbAo).
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
Time frame: 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
Time frame: 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
Time frame: Baseline (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)
Time frame: Baseline and 6 months post-stenting
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 measured from CT aortography. Unit of Measure: mmHg-¹
Time frame: Baseline and 6 months post-stenting
Aortic arch angle measured from CT aortography. Unit of Measure: degrees
Time frame: Baseline and 6 months post-stenting
Curvature of the aortic arch measured from CT aortography. Unit of Measure: cm-¹
Time frame: 6 months post-stenting
Percentage of luminal narrowing remaining after stent implantation measured by CT angiography.
Unit of Measure: %
Time frame: Baseline and 6 months post-stenting
Description: LVEF measured by cardiac MRI. Unit of Measure: %
Time frame: Baseline and 6 months post-stenting
LV global longitudinal strain measured by cardiac MRI. Unit of Measure: %
Time frame: Baseline and 6 months post-stenting
LV mass indexed to body surface area measured by cardiac MRI. Unit of Measure: g/m²
Time frame: Baseline and 6 months post-stenting
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 measured from 12-lead ECG using Bazett's formula. Unit of Measure: milliseconds
Time frame: Baseline and 6 months post-stenting
Detection of LV hypertrophy based on standard ECG voltage criteria. Unit of Measure: Categorical (present/absent)
Time frame: Baseline and 6 months post-stenting
Detection of arrhythmias using standard 12-lead ECG or Holter monitoring. Unit of Measure: Categorical (present/absent)
Contact information is provided by the study sponsor or research team.
Mena Wadee, Resident doctor
CONTACT
Noha Gamal
CONTACT
Assiut University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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