Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment

Summary

Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty or stent implantation. Although short-term results are excellent with all three treatment modalities, long term cardiovascular (CV) morbidity and mortality remain high, likely due to persistently abnormal vascular function. The effects of treatment modality on long term vascular function remain uncharacterized. The goal of this study is to assess vascular function in this patient population for comparison among the treatment modalities. Methods: Vascular function in large and small arteries will be prospectively assessed fusing multiple non-invasive modalities, and the results will be compared among the three groups of CoA patients previously treated using surgery, balloon angioplasty or stent implantation after frequency matching for confounding variables. A comprehensive vascular function assessment protocol was created to be used in 7 centers. The primary outcome is arterial stiffness measured by arterial tonometry. Inclusion and exclusion criteria were carefully established after consideration of several potential confounders. Sample size was calculated for the primary outcome variable. Conclusions: Treatment modalities for CoA may have distinct impact on large and small arterial vascular function. The results of this study will help identify the treatment modality that is associated with the most optimal level of vascular function, which, in the long term may reduce CV risk.

Conditions

• Aortic Coarctation
• Arterial Stiffness
• PULSE WAVE VELOCITY
• Functional Magnetic Resonance Imaging
• Vascular Endothelium

Interventions

PROCEDURE

Surgery

Primary end-to-end surgical treatment of coarctation of the aorta

PROCEDURE

Balloon dilation

Primary balloon dilation treatment of coarctation of the aorta

PROCEDURE

Stent

Primary stent dilation treatment of coarctation of the aorta

Sponsors & Collaborators

• Centro de Estudos de Doenças Crónicas

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Lucile Packard Children's Hospital

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Instituto Superior Técnico de Lisboa

  collaborator UNKNOWN

• Caselas, Ressonância Magnética, S.A.

  collaborator UNKNOWN

• Centro Hospitalar de Lisboa Central

  lead OTHER

Principal Investigators

• José D Martins, MD MSc · Centro Hospitalar de Lisboa Central

• Miguel Mota Carmo, MD PhD · Centro de Estudos de Doenças Crónicas da Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Eligibility

Min Age

8 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-01

Primary Completion

2017-09-30

Completion

2017-12-30

Countries

• Portugal

Study Locations