Impact of Aortic Geometry on Vascular Remodeling After Stent Implantation in Coarctation of the Aorta
NCT ID: NCT07131111
Last Updated: 2025-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2025-09-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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 ..
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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COA patients
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
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
Healthy controls
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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 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.
12 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Mina wadee fathy
Principal investigator
Principal Investigators
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Salwa Demitry Roshdy, Professor
Role: STUDY_DIRECTOR
Faculty of medicine AssiutU university
Locations
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Institutional Review Board (IRB) of Faculty of Medicine
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Vascular remodeling in COA
Identifier Type: -
Identifier Source: org_study_id
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