Aortic Stiffness by CMR in Aortic Coarctation

NCT06740461 | Not Yet Recruiting

• 1 other identifier: Aortic stiffness by CMR in CoA
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aortic Coarctation

Keywords

Aortic coarctation; Aortic stiffness; CMR; Ambulatory blood pressure

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 year

Study Arms (1)

Aortic coarctation patient

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient with aortic coarctation undergoing transcatheter aortic stenting

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 12067950 BACKGROUND

• 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.

  PMID: 23592408 BACKGROUND

• 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.

  PMID: 27084076 BACKGROUND

• 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.

  PMID: 10189008 BACKGROUND

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Shady Elia Ramzy, Master student

CONTACT

+201061327900; Shady3elia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share