Aortic CoarctationNCT06740461
Aortic Stiffness by CMR in Aortic Coarctation
An observational study of Aortic Coarctation, run by Assiut University.
Trial summary
This study investigates the correlation between medium-term systemic blood pressure control and aortic stiffness index in adults following coarctation stenting, using cardiac magnetic resonance (CMR) imaging. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Aortic Coarctation
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2027
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient with aortic coarctation undergoing transcatheter aortic stenting
Patient criteria Inclusion criteria All patients with native or recurrent aortic coarctation between the age of 14 years and older.
Transcatheter systolic gradient ≥ 20 mm Hg, body weight ≥ 20 kg, and normal LV ejection fraction (EF).
Exclusion criteria Patients with obstructive lesion of LVOT or aortic valve dysfunction greater than moderate (requiring surgical intervention).
Irregular cardiac rhythm. Patients with other causes of secondary hypertension. Contraindications to CMR: Any contraindications to undergoing CMR, such as implanted metallic devices incompatible with MRI, severe claustrophobia.
Unicuspid aortic valve 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Correlation Between Ambulatory Blood Pressure Control and Aortic Stiffness Index Assessed by CMR After Aortic Coarctation Stenting in Adults
This study investigates the correlation between medium-term systemic blood pressure control and aortic stiffness index in adults following coarctation stenting, using cardiac magnetic resonance (CMR) imaging.
Read the detailed description
Coarctation of the aorta (COA) is a common form of congenital heart disease with an incidence of 1 in 3000-4000 live births, characterized by the narrowing of the aorta, which leads to significant hemodynamic changes, including increased afterload, hypertension, and ultimately, adverse cardiovascular outcomes.
Despite successful surgical or interventional treatment to correct the anatomical defect, patients with coarctation of the aorta often continue to experience elevated systemic blood pressure and increased aortic stiffness, which are important predictors of long-term cardiovascular morbidity and mortality.
Stenting has emerged as a preferred interventional strategy for treating aortic coarctation in adults due to its less invasive nature and immediate efficacy in relieving aortic obstruction.
However, the medium-term impact of stenting on aortic stiffness remains underexplored. Understanding these changes is crucial for optimizing long-term management strategies and improving patient outcomes.
Cardiac magnetic resonance (CMR) imaging offers a non-invasive and highly accurate method for assessing aortic stiffness, providing detailed insights into the structural and functional properties of the aorta. The aortic stiffness index, derived from CMR measurements, serves as a valuable biomarker for vascular health and has been linked to systemic blood pressure levels.
This study aims to investigate the correlation between medium-term systemic blood pressure control and aortic stiffness index in adults following coarctation stenting.
By assessing patients pre- and post-stenting using CMR, we seek to determine whether improvements in aortic stiffness correspond with better blood pressure management over time. Our findings could provide valuable insights into the benefits of stenting beyond immediate hemodynamic relief, highlighting its role in the long-term cardiovascular health of patients with aortic coarctation.
- Conditions
- Aortic Coarctation
- Keywords
- Aortic coarctation, Aortic stiffness, CMR, Ambulatory blood pressure
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortic coarctation patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Systemic Blood Pressure and Aortic Stiffness Index
Evaluate the correlation between changes in systemic blood pressure and changes in the aortic stiffness index.
Measured: 1 year
Change in Systemic Blood Pressure
Measure the change in systemic blood pressure (both systolic and diastolic) by ambulatory blood pressure for 24 hours.
Measured: 1 year
Change in Aortic Stiffness Index
Measure the change in aortic stiffness index (derived from CMR) from baseline to the medium-term follow-up period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic CoarctationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Elia Ramzy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740461
- Sponsor's protocol ID
- Aortic stiffness by CMR in CoA
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. doi: 10.1136/heart.88.1.71.
PubMed 12067950Ringel RE, Vincent J, Jenkins KJ, Gauvreau K, Moses H, Lofgren K, Usmani K. Acute outcome of stent therapy for coarctation of the aorta: results of the coarctation of the aorta stent trial. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):503-10. doi: 10.1002/ccd.24949. Epub 2013 May 15.
PubMed 23592408Vonder 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 27084076Grech V. Diagnostic and surgical trends, and epidemiology of coarctation of the aorta in a population-based study. Int J Cardiol. 1999 Feb 28;68(2):197-202. doi: 10.1016/s0167-5273(98)00352-0.
PubMed 10189008
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Ambulatory Blood Pressure Control and Aortic Stiffness Index Assessed by CMR After Aortic Coarctation Stenting in Adults
- ClinicalTrials.gov ID
- NCT06740461
- Acronym / sponsor ID
- Aortic stiffness by CMR in CoA
- Conditions
- Aortic Coarctation
- Keywords
- Aortic coarctation, Aortic stiffness, CMR, Ambulatory blood pressure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (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 investigates the correlation between medium-term systemic blood pressure control and aortic stiffness index in adults following coarctation stenting, using cardiac magnetic resonance (CMR) imaging.
Detailed description
Coarctation of the aorta (COA) is a common form of congenital heart disease with an incidence of 1 in 3000-4000 live births, characterized by the narrowing of the aorta, which leads to significant hemodynamic changes, including increased afterload, hypertension, and ultimately, adverse cardiovascular outcomes.
Despite successful surgical or interventional treatment to correct the anatomical defect, patients with coarctation of the aorta often continue to experience elevated systemic blood pressure and increased aortic stiffness, which are important predictors of long-term cardiovascular morbidity and mortality.
Stenting has emerged as a preferred interventional strategy for treating aortic coarctation in adults due to its less invasive nature and immediate efficacy in relieving aortic obstruction.
However, the medium-term impact of stenting on aortic stiffness remains underexplored. Understanding these changes is crucial for optimizing long-term management strategies and improving patient outcomes.
Cardiac magnetic resonance (CMR) imaging offers a non-invasive and highly accurate method for assessing aortic stiffness, providing detailed insights into the structural and functional properties of the aorta. The aortic stiffness index, derived from CMR measurements, serves as a valuable biomarker for vascular health and has been linked to systemic blood pressure levels.
This study aims to investigate the correlation between medium-term systemic blood pressure control and aortic stiffness index in adults following coarctation stenting.
By assessing patients pre- and post-stenting using CMR, we seek to determine whether improvements in aortic stiffness correspond with better blood pressure management over time. Our findings could provide valuable insights into the benefits of stenting beyond immediate hemodynamic relief, highlighting its role in the long-term cardiovascular health of patients with aortic coarctation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic coarctation patient | – | – |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient with aortic coarctation undergoing transcatheter aortic stenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Systemic Blood Pressure and Aortic Stiffness Index
Time frame: 1 year
Evaluate the correlation between changes in systemic blood pressure and changes in the aortic stiffness index.
Change in Systemic Blood Pressure
Time frame: 1 year
Measure the change in systemic blood pressure (both systolic and diastolic) by ambulatory blood pressure for 24 hours.
Change in Aortic Stiffness Index
Time frame: 1 year
Measure the change in aortic stiffness index (derived from CMR) from baseline to the medium-term follow-up period.
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 18 Dec 2024.
- Background: PubMed 12067950Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. doi: 10.1136/heart.88.1.71.
- Background: PubMed 23592408Ringel RE, Vincent J, Jenkins KJ, Gauvreau K, Moses H, Lofgren K, Usmani K. Acute outcome of stent therapy for coarctation of the aorta: results of the coarctation of the aorta stent trial. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):503-10. doi: 10.1002/ccd.24949. Epub 2013 May 15.
- Background: 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.
- Background: PubMed 10189008Grech V. Diagnostic and surgical trends, and epidemiology of coarctation of the aorta in a population-based study. Int J Cardiol. 1999 Feb 28;68(2):197-202. doi: 10.1016/s0167-5273(98)00352-0.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Coarctation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Shady Elia Ramzy, Master student (+201061327900, Shady3elia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Systemic Blood Pressure and Aortic Stiffness Index (time frame: 1 year). The study lists 3 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 NCT06740461, which also lists 4 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 18 Dec 2024.