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Completed

NCT Number: NCT03654222

The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis

Takayasu Arteritis (TA) affects medium and large caliber arteries causing stenosis, occlusion or aneurysms. It has great predilection for the aortic arch, subclavian and extracranial arteries. The global prevalence is of 1 to 2% per million inhabitants, which varies by geographical region. The main cause of death in TA is of cardiovascular origin and includes ischemic cardiomyopathy and valvular disease. The aim of this study was to evaluate the surgical experience according to the type of surgery in subjects with TA with and without inflammatory activity.

Methods: This was a retrospective, descriptive, cross-sectional study run between 1977 and 2017. Patients with Takayasu arteritis with more than 3 classification criteria according to the American College of Rheumatology (ACR) were included. The surgeries were classified as: Organ preservation, cardiac, bypass, exclusion and replacement. Inflammatory activity was evaluated.

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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nacional Institute of Cardiology

Mexico City, 14080, Mexico

About this study

A review of the clinical records of patients diagnosed with TA with more than 3 criteria of the American College of Rheumatology (ACR) and undergoing some surgical procedure by the Surgery Service of the National Institute of Cardiology "Ignacio Chávez", in a period of time comprised between 1977 and 2016 was done. Patients of any gender and age who had been operated on by a surgical procedure registered in their medical record were included. Patients intervened in other institutions were excluded. The surgical event was classified into 6 groups: 1) organ-preservation surgery (mainly renal autograft); 2) Bypass (revascularization of affected organs or segments with Woven Dacron graft); 3) Replacement (replacement of affected aortic segment with a Woven Dacron graft); 4) Cardiac Surgery (direct procedures in heart); 5) Exclusion (resection of an affected organ (nephrectomy)), and 6) Other.

Inflammatory activity was evaluated according to the Dabague-Reyes criteria, in which a score greater than or equal to 5 is considered as active inflammation (9).

Statistical analysis: Variables with a loss of the sample data greater than 20% were excluded. The categorical variables were described by percentages and prevalences and the comparison were done by chi square or Fisher's exact test. A statistically significant level was considered when an error α <0.05 was found. Parametric numerical variables are described by measures of central tendency and the comparison is made by Student's T test. The survival analysis was performed using Kaplan-Meier. Ethical aspects were considered according to the Helsinky declaration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of any gender regardless of age that has a diagnosis of TA established by a rheumatologist,
  • Have a surgical procedure registered in your medical record

Exclusion criteria

  • Not having a digital, physical or microfilmed medical record
  • Surgical procedures performed at another institution

Treatment and study plan

Primary outcomes

  1. Long-term survival rate surgery event

    Time frame: 45 years

    Observed in our study in relation to the mortality associated with the surgical event

  2. Long-term survival according from other causes

    Time frame: 30 years

    According to the type of surgery in relation to mortality from other causes

Secondary outcomes

  1. Arterial lesions

    Time frame: 30 years

    According to Numano's classification

  2. Inflammatory activity

    Time frame: 30 years

    Evaluated according to the Dabague-Reyes criteria

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Registry information

Official study title

The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis. 30 Years of Experience in Mexico, Beyond Forefront Techniques

Important dates

Study start
1977
Primary completion
2016
Study completion
2017
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

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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