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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorAssiut University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population will consist of two groups: 1. Patients group: Individuals diagnosed with coarctation of the aorta (CoA) who have undergone successful stent implantation and will be evaluated six months post-stenting. 2. Control group: Age- and sex-matched healthy volunteers with no history of cardiovascular or systemic diseases. 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • CT aortography

    Radiation

    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

    Radiation

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: COA patients2 interventions
Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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)
2

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
3

Aortic Distensibility

Aortic distensibility measured from CT aortography. Unit of Measure: mmHg-¹

Time frame
Baseline and 6 months post-stenting
4

Aortic Arch Angle

Aortic arch angle measured from CT aortography. Unit of Measure: degrees

Time frame
Baseline and 6 months post-stenting

Other outcomes

Sponsors and contacts

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