Aortic GeometryNCT07131111
Impact of Aortic Geometry on Vascular Remodeling After Stent Implantation in Coarctation of the Aorta
An observational study of Aortic Geometry and Vascular Remodeling, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Geometry, Vascular Remodeling, Coarctation of Aorta
- What is being tested?
- CT aortography and CMR
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Institutional Review Board (IRB) of Faculty of Medicine
Asyut
Assiut University, +2088 22080150, irbasyut@aun.edu.eg
About this study
This study aims to assess:
- Aortic geometrical changes and their relationship to hypertension and cardiovascular events.
- Aortic geometrical differences between healthy individuals and patients with repaired coarctation of the aorta.
Read the detailed description
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 ..
- Conditions
- Aortic Geometry, Vascular Remodeling, Coarctation of Aorta, Blood Pressure, Residual Stenosis, CT Aortography
- Being tested
- CT aortography, CMR
- Medical subject headings
- Vascular Remodeling, Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT aortographyRadiation
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
CMRRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| COA patients | Not described Receives: Radiation: CT aortography; Radiation: CMR | |
| Healthy controls | Not described Receives: Radiation: CT aortography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 6 months post-stenting
Secondary outcomes (13)
Aortic Arch Morphology Classification
Classification of aortic arch morphology (normal, gothic, crenel) based on CT aortography.
Unit of Measure: Categorical (normal/gothic/crenel)
Measured: 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
Measured: Baseline and 6 months post-stenting
Aortic Distensibility
Aortic distensibility measured from CT aortography. Unit of Measure: mmHg-¹
Measured: Baseline and 6 months post-stenting
Aortic Arch Angle
Aortic arch angle measured from CT aortography. Unit of Measure: degrees
Measured: Baseline and 6 months post-stenting
Aortic Arch Curvature
Curvature of the aortic arch measured from CT aortography. Unit of Measure: cm-¹
Measured: Baseline and 6 months post-stenting
Residual Stenosis
Percentage of luminal narrowing remaining after stent implantation measured by CT angiography.
Unit of Measure: %
Measured: 6 months post-stenting
Left Ventricular Ejection Fraction (LVEF)
Description: LVEF measured by cardiac MRI. Unit of Measure: %
Measured: Baseline and 6 months post-stenting
LV Global Longitudinal Strain
LV global longitudinal strain measured by cardiac MRI. Unit of Measure: %
Measured: 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
Measured: 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
Measured: Baseline and 6 months post-stenting
QTc Dispersion
QTc dispersion measured from 12-lead ECG using Bazett's formula. Unit of Measure: milliseconds
Measured: 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)
Measured: 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)
Measured: Baseline and 6 months post-stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic GeometryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina wadee fathy, Assiut University
- Investigators
- Salwa Demitry Roshdy, Professor, Study director, Faculty of medicine AssiutU university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131111
- Sponsor's protocol ID
- Vascular remodeling in COA
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25559379Toro-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.
PubMed 11867038Parati 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.
PubMed 18622223Iriart 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.
PubMed 30585428Pushparajah 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.
PubMed 31730044Faganello 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.
PubMed 29940971Agasthi 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.
PubMed 32547712Ou 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.
PubMed 17059930Ou 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.
PubMed 15474701Vonder 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.
PubMed 27084076
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aortic Geometry on Vascular Remodeling After Stent Implantation in Coarctation of the Aorta
- ClinicalTrials.gov ID
- NCT07131111
- Acronym / sponsor ID
- Vascular remodeling in COA
- Conditions
- Aortic Geometry, Vascular Remodeling, Coarctation of Aorta, Blood Pressure, Residual Stenosis, CT Aortography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess:
- Aortic geometrical changes and their relationship to hypertension and cardiovascular events.
- Aortic geometrical differences between healthy individuals and patients with repaired coarctation of the aorta.
Detailed description
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 ..
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COA patients | – | Radiation: CT aortography, Radiation: CMR |
| Healthy controls | – | Radiation: CT aortography |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT aortographyPerformed 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 | Radiation | COA patients, Healthy controls |
| CMRCMR 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 | Radiation | COA patients |
Primary outcome
Change in Systolic Blood Pressure
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
Change in Diastolic Blood Pressure
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
13 secondary outcomes
Aortic Arch Morphology Classification
Time frame: Baseline (within hospital stay, up to 2 days)
Aortic Elasticity
Time frame: Baseline and 6 months post-stenting
Aortic Distensibility
Time frame: Baseline and 6 months post-stenting
Aortic Arch Angle
Time frame: Baseline and 6 months post-stenting
Aortic Arch Curvature
Time frame: Baseline and 6 months post-stenting
Residual Stenosis
Time frame: 6 months post-stenting
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and 6 months post-stenting
LV Global Longitudinal Strain
Time frame: Baseline and 6 months post-stenting
LV Mass Index (LVMI)
Time frame: Baseline and 6 months post-stenting
Left Atrial Volume Index (LAVI)
Time frame: Baseline and 6 months post-stenting
QTc Dispersion
Time frame: Baseline and 6 months post-stenting
Presence of Left Ventricular Hypertrophy on ECG
Time frame: Baseline and 6 months post-stenting
Presence of Arrhythmia
Time frame: Baseline and 6 months post-stenting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Results publication: PubMed 25559379Shepherd 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.
- Results publication: PubMed 11867038Toro-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.
- Results publication: PubMed 18622223Parati 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.
- Results publication: PubMed 30585428Iriart 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.
- Results publication: PubMed 31730044Pushparajah 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.
- Results publication: PubMed 29940971Faganello 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.
- Results publication: PubMed 32547712Agasthi 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.
- Results publication: PubMed 17059930Ou 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.
- Results publication: PubMed 15474701Ou 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.
- Results publication: PubMed 27084076Vonder 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salwa Demitry Roshdy, Professor study director
Faculty of medicine AssiutU university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Geometry and Vascular Remodeling, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mena Wadee, Resident doctor (01282210873, menawade399@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (time frame: Baseline and 6 months post-stenting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131111, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.