LOVE-COARCT Study: Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vascular function
研究概览
简要总结
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.
详细描述
Study overview. This cross-sectional prospective observational study of patients with CoA previously treated using one of three treatment modalities assesses if treatment type is associated with differences in vascular function. The three treatment groups will be frequency-matched for key confounding variables.
Study feasibility. The investigators assembled a multi-disciplinary team with proven expertise in epidemiology, clinical trial design, congenital heart disease, non-invasive imaging, interventional cardiology, vascular function assessment, preventive cardiology and statistical analysis. A multicenter design is used to ensure sufficient statistical power in evaluating the hypothesis.
Participating centers and study core laboratories. Patients are recruited at six large pediatric cardiac centers from Portugal and USA.
Screening procedures. The medical records of potentially eligible patients are screened by a local study investigator using a pre-specified screening form to ensure that they satisfy our selection criteria.
Overview of the study workflow. Study procedures will occur in a one- or two-day visit. Upon arrival for testing, formal consent for participation will be obtained. Assessment of arterial stiffness, endothelial function, and blood sampling for biomarkers will be done while fasting. Cardiopulmonary stress test will be performed on the same day. CMR and ambulatory blood pressure monitoring (ABMP) will be arranged for the same or for the following day. When the study tests cannot be completed at the first visit, they will be completed within 3 months of the first visit. The study protocol was approved by the Institutional Review Board or Institutional Ethics Committee at each participating center, and informed consent and assent will be obtained, depending on age, from patients and their parents/legal guardians before trial enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of isthmic coarctation of the aorta;
- •Current age between 8 (to allow cooperation with study procedures) and 35 years (to avoid confounding by aging-related vascular dysfunction); and
- •Treatment for CoA after 1994, after which all three modalities were in clinical use.
排除标准
- •Residual CoA defined by a systolic upper-to-lower extremity BP gradient> 20mmHg;
- •Co-morbidities that may independently affect vascular function, including associated significant congenital heart disease, history of known vasculopathy, genetic syndromes or other cardiovascular risk factors;
- •History of two treatment types for CoA; and
- •CoA types likely representing a different entity or patients amenable to one single treatment type (surgery), including atypical CoA site (such as mid-thoracic or abdominal), severe hypoplasia of the aortic arch, and an age of treatment <1 year of age.
结局指标
主要结局
Vascular function
时间窗: 6 months to 35 years after primary treatment
Arterial stiffness assessed with carotid-femoral PWV measurements by tonometry
次要结局
- Pulse wave form(6 months to 35 years after primary treatment)
- Cardiac Magnetic Resonance functional indexes(6 months to 35 years after primary treatment)
- Blood pressure phenotype(6 months to 35 years after primary treatment)
- Biomarkers of vascular wall function(6 months to 35 years after primary treatment)
- Biomarkers of endothelial function(6 months to 35 years after primary treatment)
- Endothelial function(6 months to 35 years after primary treatment)
- Left ventricular systolic function(6 months to 35 years after primary treatment)
- Left ventricular mass(6 months to 35 years after primary treatment)
- Biomarkers of vascular inflammation(6 months to 35 years after primary treatment)
- Biomarkers of vascular remodeling(6 months to 35 years after primary treatment)