Clinical trial NCT03654222: The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis
Official title: The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis. 30 Years of Experience in Mexico, Beyond Forefront Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteritis, Takayasu
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 66
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A review of clinical records of patients with diagnosis of Takayasu arteritis and undergoing some surgical procedure by the surgery service of the National Institute of Cardiology "Ignacio Chávez", in a period between 1977 and 2016 was conducted.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Long-term survival rate surgery event
timeFrame: 45 years
measure: Long-term survival according from other causes
timeFrame: 30 years
Secondary outcomes:
measure: Arterial lesions
timeFrame: 30 years
measure: Inflammatory activity
timeFrame: 30 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Nacional Institute of Cardiology
state: Cdmx
Study officials:
References:
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