Aortic Stiffness by CMR in Aortic Coarctation

NCT ID: NCT06740461

Last Updated: 2024-12-18

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Aortic Coarctation

Keywords

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Aortic coarctation Aortic stiffness CMR Ambulatory blood pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Aortic coarctation patient

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Transcatheter systolic gradient ≥ 20 mm Hg, body weight ≥ 20 kg, and normal LV ejection fraction (EF).

Exclusion Criteria

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shady Elia Ramzy

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shady Elia Ramzy, Master student

Role: CONTACT

Phone: +201061327900

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 12067950 (View on PubMed)

Ringel 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.

Reference Type BACKGROUND
PMID: 23592408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27084076 (View on PubMed)

Grech 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.

Reference Type BACKGROUND
PMID: 10189008 (View on PubMed)

Other Identifiers

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Aortic stiffness by CMR in CoA

Identifier Type: -

Identifier Source: org_study_id