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

NCT07131111 | Not Yet Recruiting DMC

• 1 other identifier: Vascular remodeling in COA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess:

1. 1.Aortic geometrical changes and their relationship to hypertension and cardiovascular events.
2. 2.Aortic geometrical differences between healthy individuals and patients with repaired coarctation of the aorta.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline and 6 months post-stenting

Secondary Outcomes (13)

• Aortic Arch Morphology Classification

  Baseline (within hospital stay, up to 2 days)

• Aortic Elasticity

  Baseline and 6 months post-stenting

• Aortic Distensibility

  Baseline and 6 months post-stenting

• Aortic Arch Angle

  Baseline and 6 months post-stenting

• Aortic Arch Curvature

  Baseline and 6 months post-stenting

Study Arms (2)

COA patients

Radiation: CT aortography; Radiation: CMR

Healthy controls

Radiation: CT aortography

Interventions

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

COA patients; Healthy controls

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

COA patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Institutional Review Board (IRB) of Faculty of Medicine

Asyut, Egypt

Location

Related Publications (10)

• Shepherd B, Abbas A, McParland P, Fitzsimmons S, Shambrook J, Peebles C, Brown I, Harden S. MRI in adult patients with aortic coarctation: diagnosis and follow-up. Clin Radiol. 2015 Apr;70(4):433-45. doi: 10.1016/j.crad.2014.12.005. Epub 2015 Jan 3.

  PMID: 25559379 BACKGROUND

• Toro-Salazar OH, Steinberger J, Thomas W, Rocchini AP, Carpenter B, Moller JH. Long-term follow-up of patients after coarctation of the aorta repair. Am J Cardiol. 2002 Mar 1;89(5):541-7. doi: 10.1016/s0002-9149(01)02293-7.

  PMID: 11867038 BACKGROUND

• Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, Kario K, Lurbe E, Manolis A, Mengden T, O'Brien E, Ohkubo T, Padfield P, Palatini P, Pickering T, Redon J, Revera M, Ruilope LM, Shennan A, Staessen JA, Tisler A, Waeber B, Zanchetti A, Mancia G; ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary report of the Second International Consensus Conference on Home Blood Pressure Monitoring. J Hypertens. 2008 Aug;26(8):1505-26. doi: 10.1097/HJH.0b013e328308da66.

  PMID: 18622223 BACKGROUND

• Iriart X, Laik J, Cremer A, Martin C, Pillois X, Jalal Z, Roubertie F, Thambo JB. Predictive factors for residual hypertension following aortic coarctation stenting. J Clin Hypertens (Greenwich). 2019 Feb;21(2):291-298. doi: 10.1111/jch.13452. Epub 2018 Dec 25.

  PMID: 30585428 BACKGROUND

• Pushparajah K, Duong P, Mathur S, Babu-Narayan S. EDUCATIONAL SERIES IN CONGENITAL HEART DISEASE: Cardiovascular MRI and CT in congenital heart disease. Echo Res Pract. 2019 Oct 1;6(4):R121-38. doi: 10.1530/ERP-19-0048. Online ahead of print.

  PMID: 31730044 BACKGROUND

• Faganello G, Cioffi G, Rossini M, Ognibeni F, Giollo A, Fisicaro M, Russo G, Di Nora C, Doimo S, Tarantini L, Mazzone C, Cherubini A, D'Agata Mottolesi B, Pandullo C, Di Lenarda A, Sinagra G, Viapiana O. Are aortic coarctation and rheumatoid arthritis different models of aortic stiffness? Data from an echocardiographic study. Cardiovasc Ultrasound. 2018 Jun 26;16(1):9. doi: 10.1186/s12947-018-0126-y.

  PMID: 29940971 BACKGROUND

• Agasthi P, Pujari SH, Tseng A, Graziano JN, Marcotte F, Majdalany D, Mookadam F, Hagler DJ, Arsanjani R. Management of adults with coarctation of aorta. World J Cardiol. 2020 May 26;12(5):167-191. doi: 10.4330/wjc.v12.i5.167.

  PMID: 32547712 BACKGROUND

• Ou P, Mousseaux E, Celermajer DS, Pedroni E, Vouhe P, Sidi D, Bonnet D. Aortic arch shape deformation after coarctation surgery: effect on blood pressure response. J Thorac Cardiovasc Surg. 2006 Nov;132(5):1105-11. doi: 10.1016/j.jtcvs.2006.05.061.

  PMID: 17059930 BACKGROUND

• Ou P, Bonnet D, Auriacombe L, Pedroni E, Balleux F, Sidi D, Mousseaux E. Late systemic hypertension and aortic arch geometry after successful repair of coarctation of the aorta. Eur Heart J. 2004 Oct;25(20):1853-9. doi: 10.1016/j.ehj.2004.07.021.

  PMID: 15474701 BACKGROUND

• Vonder Muhll IF, Sehgal T, Paterson DI. The Adult With Repaired Coarctation: Need for Lifelong Surveillance. Can J Cardiol. 2016 Aug;32(8):1038.e11-5. doi: 10.1016/j.cjca.2015.12.036. Epub 2016 Jan 21.

  PMID: 27084076 BACKGROUND

MeSH Terms

Conditions

Vascular Remodeling; Aortic Coarctation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Salwa Demitry Roshdy, Professor

  Faculty of medicine AssiutU university

  STUDY DIRECTOR

Central Study Contacts

Mena Wadee, Resident doctor

CONTACT

01282210873; menawade399@gmail.com

Noha Gamal

CONTACT

+201002295166; noha_cardio@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

EG (1)