NCT03654222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 1977

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1977

Completed
40 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

40 years

First QC Date

August 29, 2018

Last Update Submit

August 29, 2018

Conditions

Arteritis, Takayasu

Outcome Measures

Primary Outcomes (2)

  • Long-term survival rate surgery event

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

    45 years

  • Long-term survival according from other causes

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

    30 years

Secondary Outcomes (2)

  • Arterial lesions

    30 years

  • Inflammatory activity

    30 years

Study Arms (6)

Cardiac surgery

Direct procedures in heart

Organ preservation

Mainly renal autograft

Bypass

Revascularization of affected organs or segments with Woven Dacron graft

Exclusion

Resection of an affected organ (nephrectomy)

Replacement

Replacement of affected aortic segment with a Woven Dacron graft

Other

Any surgery that does not include the previous ones

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nacional Institute of Cardiology

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (21)

  • Serra R, Butrico L, Fugetto F, Chibireva MD, Malva A, De Caridi G, Massara M, Barbetta A, Cannistra M, de Franciscis S. Updates in Pathophysiology, Diagnosis and Management of Takayasu Arteritis. Ann Vasc Surg. 2016 Aug;35:210-25. doi: 10.1016/j.avsg.2016.02.011. Epub 2016 May 27.

    PMID: 27238990BACKGROUND

  • Hoffman GS. Takayasu arteritis: lessons from the American National Institutes of Health experience. Int J Cardiol. 1996 Aug;54 Suppl:S99-102. doi: 10.1016/s0167-5273(96)88778-x.

    PMID: 9119532BACKGROUND

  • Lazzarin P, Pasero G, Marson P, Cecchetto A, Zanchin G. [Takayasu's arteritis. A concise review and some observations on a putative case reported by Giovanni Battista Morgagni (1761)]. Reumatismo. 2005 Dec;57(4):305-13. doi: 10.4081/reumatismo.2005.305. Italian.

    PMID: 16380760BACKGROUND

  • SHIMIZU K, SANO K. Pulseless disease. J Neuropathol Clin Neurol. 1951 Jan;1(1):37-47. No abstract available.

    PMID: 24538949BACKGROUND

  • Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. doi: 10.1016/s0167-5273(96)88783-3.

    PMID: 9119516BACKGROUND

  • Park SJ, Kim HJ, Park H, Hann HJ, Kim KH, Han S, Kim Y, Ahn HS. Corrigendum to "Incidence, prevalence, mortality and causes of death in Takayasu Arteritis in Korea - A nationwide, population-based study" [Int. J. Cardiol., 235(2017), 100-104]. Int J Cardiol. 2017 Jul 1;238:182. doi: 10.1016/j.ijcard.2017.04.013. Epub 2017 Apr 24. No abstract available.

    PMID: 28449826BACKGROUND

  • Dabague J, Reyes PA. Takayasu arteritis in Mexico: a 38-year clinical perspective through literature review. Int J Cardiol. 1996 Aug;54 Suppl:S103-9. doi: 10.1016/s0167-5273(96)88779-1.

    PMID: 9119510BACKGROUND

  • Soto ME, Espinola N, Flores-Suarez LF, Reyes PA. Takayasu arteritis: clinical features in 110 Mexican Mestizo patients and cardiovascular impact on survival and prognosis. Clin Exp Rheumatol. 2008 May-Jun;26(3 Suppl 49):S9-15.

    PMID: 18799047BACKGROUND

  • Lupi-Herrera E, Sanchez-Torres G, Marcushamer J, Mispireta J, Horwitz S, Vela JE. Takayasu's arteritis. Clinical study of 107 cases. Am Heart J. 1977 Jan;93(1):94-103. doi: 10.1016/s0002-8703(77)80178-6.

    PMID: 12655BACKGROUND

  • Schmidt J, Kermani TA, Bacani AK, Crowson CS, Cooper LT, Matteson EL, Warrington KJ. Diagnostic features, treatment, and outcomes of Takayasu arteritis in a US cohort of 126 patients. Mayo Clin Proc. 2013 Aug;88(8):822-30. doi: 10.1016/j.mayocp.2013.04.025. Epub 2013 Jul 10.

    PMID: 23849994BACKGROUND

  • Nazareth R, Mason JC. Takayasu arteritis: severe consequences of delayed diagnosis. QJM. 2011 Sep;104(9):797-800. doi: 10.1093/qjmed/hcq193. Epub 2010 Oct 15. No abstract available.

    PMID: 20952441BACKGROUND

  • Rosa Neto NS, Shinjo SK, Levy-Neto M, Pereira RMR. Vascular surgery: the main risk factor for mortality in 146 Takayasu arteritis patients. Rheumatol Int. 2017 Jul;37(7):1065-1073. doi: 10.1007/s00296-017-3656-y. Epub 2017 Feb 21.

    PMID: 28224216BACKGROUND

  • Ogino H, Matsuda H, Minatoya K, Sasaki H, Tanaka H, Matsumura Y, Ishibashi-Ueda H, Kobayashi J, Yagihara T, Kitamura S. Overview of late outcome of medical and surgical treatment for Takayasu arteritis. Circulation. 2008 Dec 16;118(25):2738-47. doi: 10.1161/CIRCULATIONAHA.107.759589. No abstract available.

    PMID: 19106398BACKGROUND

  • Ishikawa K. Natural history and classification of occlusive thromboaortopathy (Takayasu's disease). Circulation. 1978 Jan;57(1):27-35. doi: 10.1161/01.cir.57.1.27.

    PMID: 21760BACKGROUND

  • Saadoun D, Lambert M, Mirault T, Resche-Rigon M, Koskas F, Cluzel P, Mignot C, Schoindre Y, Chiche L, Hatron PY, Emmerich J, Cacoub P. Retrospective analysis of surgery versus endovascular intervention in Takayasu arteritis: a multicenter experience. Circulation. 2012 Feb 14;125(6):813-9. doi: 10.1161/CIRCULATIONAHA.111.058032. Epub 2012 Jan 9.

    PMID: 22230484BACKGROUND

  • Mwipatayi BP, Jeffery PC, Beningfield SJ, Matley PJ, Naidoo NG, Kalla AA, Kahn D. Takayasu arteritis: clinical features and management: report of 272 cases. ANZ J Surg. 2005 Mar;75(3):110-7. doi: 10.1111/j.1445-2197.2005.03312.x.

    PMID: 15777385BACKGROUND

  • Kaku Y, Aomi S, Tomioka H, Yamazaki K. Surgery for aortic regurgitation and aortic root dilatation in Takayasu arteritis. Asian Cardiovasc Thorac Ann. 2015 Oct;23(8):901-6. doi: 10.1177/0218492315591291. Epub 2015 Jun 18.

    PMID: 26089524BACKGROUND

  • Miyata T, Sato O, Koyama H, Shigematsu H, Tada Y. Long-term survival after surgical treatment of patients with Takayasu's arteritis. Circulation. 2003 Sep 23;108(12):1474-80. doi: 10.1161/01.CIR.0000089089.42153.5E. Epub 2003 Sep 2.

    PMID: 12952846BACKGROUND

  • Li J, Zhu M, Li M, Zheng W, Zhao J, Tian X, Zeng X. Cause of death in Chinese Takayasu arteritis patients. Medicine (Baltimore). 2016 Jul;95(27):e4069. doi: 10.1097/MD.0000000000004069.

    PMID: 27399093BACKGROUND

  • Chiche L, Kieffer E, Sabatier J, Colau A, Koskas F, Bahnini A. Renal autotransplantation for vascular disease: late outcome according to etiology. J Vasc Surg. 2003 Feb;37(2):353-61. doi: 10.1067/mva.2003.84.

    PMID: 12563206BACKGROUND

  • Carlson JA. The histological assessment of cutaneous vasculitis. Histopathology. 2010 Jan;56(1):3-23. doi: 10.1111/j.1365-2559.2009.03443.x.

    PMID: 20055902RESULT

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH DOCTOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

January 1, 1977

Primary Completion

December 31, 2016

Study Completion

June 26, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)