Association Between Stroke and Adrenal Incidentalomas

Stroke Clinical Trial

— ABSAI  

Official title:

If Adrenal Incidentalomas Have the Influences to Occur and Progress in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237817
• Other study ID #: yanh-stroke&adrenal
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: February 28, 2029

Study information

• Verified date: April 2021
• Source: Xuanwu Hospital, Beijing
• Contact: Hao Yan, Dr.
• Phone: +86-13651341058
• Email: yanhurology[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Adrenal incidentalomas (AIs) are commonly encountered in transsection imaging which purpose not for suspected adrenal disease. However, part of AIs in patients is associated with Stroke. Stroke is a diseases which could cause of disability and death worldwide. In clinical practice, detailed information about the association between stroke and AIs is not available. In this study, the investigators aimed to investigate the risk for disability and death in the large group of stroke patients with AIs.

Description:

Background:

Adrenal incidentalomas (AIs) are commonly encountered in transsection imaging which purpose not for suspected adrenal disease. However, part of AIs in patients is associated with Stroke . The investigators aimed to investigate the risk for disability and death in the large group of stroke patients with AIs.

Objective:

To measure the association between stroke and levels of autonomous cortisol secretion in patients with AIs.

Design:

Part 1, Retrospective cohort study.

From April 1, 2021, to September 30, 2021, cohort patients with stroke were recruited in this study. The investigators assess the standardised incidence rate of AIs in all patients. Meanwhile, detail information about stroke disease、patient and AIs characteristics were record.

Part 2, Prospective cohort study.

From Mar 1, 2022, to Feb 29, 2024, cohort patients with stroke plane to recruit in this study. All patient receive the plasma cortisol level after a 1-mg dexamethasone suppression test. The investigators assess the standardised incidence rate of AIs in all patients. Meanwhile, detail information about stroke disease、patient and AIs characteristics would be record.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: February 28, 2029
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• stroke disease , such as Cerebral infarction?Intracerebral hemorrhage and Subarachnoid hemorrhage.

Exclusion Criteria:

• presence of metastatic cancer;

• AIs smaller than 1 cm;

• nonadenoma lesions, such as myelolipomas,hemorrhages, and cysts;

• oral glucocorticoid treatment with more than single doses in the past 3 months;

• use of inhaled steroids or medication affecting dexamethasone metabolism;

• systemic estrogen treatment.

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Incidentaloma
• Adrenocortical Adenoma
• Stroke

Locations

Country	Name	City	State
China	Hao Yan	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (3)

Ebbehoj A, Li D, Kaur RJ, Zhang C, Singh S, Li T, Atkinson E, Achenbach S, Khosla S, Arlt W, Young WF, Rocca WA, Bancos I. Epidemiology of adrenal tumours in Olmsted County, Minnesota, USA: a population-based cohort study. Lancet Diabetes Endocrinol. 2020 Nov;8(11):894-902. doi: 10.1016/S2213-8587(20)30314-4. — View Citation

Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467. — View Citation

Kjellbom A, Lindgren O, Puvaneswaralingam S, Löndahl M, Olsen H. Association Between Mortality and Levels of Autonomous Cortisol Secretion by Adrenal Incidentalomas : A Cohort Study. Ann Intern Med. 2021 Aug;174(8):1041-1049. doi: 10.7326/M20-7946. Epub 2021 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of Adrenal incidentalomas	Assess the standardised incidence rate of AIs in all patients with stroke	5 years
Primary	Plasma cortisol level	Plasma cortisol level after a 1-mg dexamethasone suppression test	5 years
Secondary	Diameter of Adrenal incidentalomas	Maximal axial diameter of adrenal incidentalomas by computed tomography scan; Millimetre as a metric unit of length in this study	5 years