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NCT Number: NCT06740461

Aortic Stiffness by CMR in Aortic Coarctation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shady Elia Ramzy, Master student

CONTACT

[email protected]

+201061327900

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Correlation Between Ambulatory Blood Pressure Control and Aortic Stiffness Index Assessed by CMR After Aortic Coarctation Stenting in Adults

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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