An observational study in Aortic Coarctation, sponsored by Assiut University. Not yet recruiting. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Assiut University · Observational
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.
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 (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. 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2024; primary completion for Dec 2025, 12 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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